Podcasts about Merck

Dr. Monty Pal and Dr. Vamsi Velcheti discuss the evolving treatment landscape in EGFR-mutated non-small cell lung cancer, including landmark trials like FLAURA2, novel drug therapies, and the growing importance of ctDNA and MRD testing. TRANSCRIPT Dr. Monty Pal: Hello, and welcome to the ASCO Daily News Podcast. I'm your host, Dr. Monty Pal. I'm a medical oncologist and professor and vice chair of academic affairs at the City of Hope Comprehensive Cancer Center in Los Angeles. Today, I'm truly delighted to introduce Dr. Vamsi Velcheti, who's a professor of medicine and the chief of hematology-oncology at the Mayo Clinic in Jacksonville, Florida. We'll be discussing the expanding treatment landscape in EGFR-positive lung cancer and how to navigate the challenges of balancing treatment efficacy, toxicity, and patient quality of life in the EGFR-positive space.  Just FYI, our full disclosures are available in the transcript of this episode.  Vamsi, it's so great to have you on the podcast. Thank you so much for being here. Dr. Vamsi Velcheti: Thank you, Monty. It's a pleasure to be here with you. It's a really exciting topic and there are a lot of updates in the EGFR space. Dr. Monty Pal: So, I'm going to need your help with this because I'll be honest with you, I see very little lung cancer, if any, in my practice. I'm pretty much exclusively kidney cancer these days. I'm coming on 20 years at City of Hope now, and I still remember when trials like ECOG 1599 were presented with, you know, platinum doublets. And, of course, the field has changed a lot since then. But tell us a little bit about the first-line landscape, and I think just for the sake of time, we're going to stick with EGFR-positive disease here. What does it look like these days? Dr. Vamsi Velcheti: Monty, the foundation of care remains the third-generation EGFR inhibitors. These are selective EGFR inhibitors, like osimertinib. We've had an evolution of the development of these TKIs. Like, you know, we had the first-generation, second-generation, not-so-selective EGFR inhibitors. Now we have mutant-selective EGFR inhibitors in the clinic, and they're doing a really good job. And these are quite effective in patients who have classical activating mutations. But the reality is that these have not been transformative. These agents have fundamentally changed the response patterns, excellent CNS penetration, and very good tolerability profile. However, we don't see a lot of durability in terms of the response. So, what's different today is now there have been several trials in combination with these third-generation EGFR inhibitors that have really laid the foundation of how we kind of think about EGFR-positive disease. At the high level, there are a lot of challenges to selecting the patients for these combination-based modalities. I'm assuming we'll be talking more about these different trials and different approaches. Some of these combination-based strategies have really moved the needle in terms of improving overall survival and really improving long-term outcomes and durability in our patients. Dr. Monty Pal: And we are going to get into the weeds on this in just a moment. But I did kick off this podcast talking about chemotherapy, ECOG 1599. It does seem as though chemotherapy is still a component of management in advanced non-small cell lung cancer. So, can you tell us about, perhaps first, you mentioned osimertinib, you know, some of these next-generation EGFR inhibitors. Tell us about the role of chemo plus osimertinib. Dr. Vamsi Velcheti: That's exactly where I was going with the combination-based strategies. You know, we first started off with our earlier trials in the EGFR space evaluating the question of, are targeted therapies, are these highly effective, third-generation, EGFR-selective inhibitors, superior to platinum-doublet chemotherapy? And we've had multiple trials demonstrating that, like the FLAURA trial and in the past with second-generation EGFR inhibitors like erlotinib and gefitinib and afatinib. So, we know that these TKIs actually perform better than platinum-doublet chemotherapy. Now, we have a large, global, phase 3 trial data from the FLAURA2 trial, which looks at the question, "Hey, you know, osimertinib is better than chemotherapy, platinum-doublet chemotherapy. Can we do even better by combining osimertinib with platinum-doublet chemotherapy?" So, FLAURA2 answered that question. This is a large, phase 3 trial, and it's a positive trial with improved durability of disease control and improving overall survival with combination with chemotherapy. So, it's a very important and landmark trial, and essentially combining osimertinib with a platinum-based chemotherapy improved responses, deepened responses, and improved overall survival and really changing the disease trajectory. And this strategy is definitely compelling, especially in patients who have certain clinical high-risk features like, you know, patients who have high disease burden or patients who are sometimes having rapid disease progression early on osimertinib, especially with patients who have a lot of visceral disease burden. So, intensifying treatments up front could alter the natural trajectory of the disease. Dr. Monty Pal: So, you sort of alluded to this in that last part there, but is that kind of how you in clinical practice select? Is it based on, you know, visceral involvement? Is it based on rapidity of disease where you think about adding chemotherapy to osimertinib? Maybe you can give us the corollary. Which patients do you just use osimertinib alone in, for instance? Dr. Vamsi Velcheti: Definitely, there are some patients who have low disease burden and they have the classical mutations, like an exon 19 deletion. And these patients, especially if they don't have a lot of disease burden, they don't have CNS involvement, there may be a subset of patients who could just do fine on osimertinib of course, with close monitoring of the disease. I guess we'll get into that later, how do we do that with either ctDNA or like closer imaging or both. So, there may be some opportunity to kind of escalate patients' treatments based on certain clinical characteristics or radiographic characteristics or certain biological characteristics informed by ctDNA or other approaches. Dr. Monty Pal: No, that's interesting. And you're right, we will chat about ctDNA in just a bit. But before we get there, I think one of the big agents that has really sort of come to the fore in advanced non-small cell lung cancer is amivantamab. I've heard a lot about this in the context of even kidney cancer because in certain subsets, I'm interested in MET-directed therapies and so forth, right? So maybe tell us a little bit about the mechanism of amivantamab first, and then maybe tell us about this pivotal MARIPOSA trial where it's combined with lazertinib. Dr. Vamsi Velcheti: So, the MARIPOSA trial compared lazertinib alone with amivantamab plus lazertinib. And this trial demonstrated overall survival advantage, and there were key differences in terms of tolerability and the safety of amivantamab, which is an EGFR and MET bispecific, and there were certain kind of unique toxicity profiles that make it a little different than the intensification approach with chemotherapy through the FLAURA2 trial. So, there's a trade-off in terms of the toxicity profile. It's a different agent and a different management protocol in terms of dermatological toxicity management that clinicians need to be comfortable with. And also, there are certain unique issues in terms of amivantamab; there's a higher rate of infusion-related reactions, there's an increased risk for edema and VTEs because of amivantamab. Certainly a different toxicity profile, different management paradigm there in terms of longitudinal care of these patients requiring dermatological care and like, you know, close monitoring and prophylaxis VTEs. But having said that, definitely it's a different strategy, and it kind of changes the biology and the natural history of the cancers, and we do see some durability of responses that we see with the MARIPOSA. So, it's certainly a great alternative, at least for some patients. Dr. Monty Pal: That was a great overview of MARIPOSA. Now comes the really difficult question, which is, how do you choose between the two? You have these two great options, right, for EGFR-positive patients. You've already highlighted some of the distinctions in terms of toxicity. I think the audience is well aware of the side effects of chemo-doublet, perhaps even the EGFR-based therapies. Amivantamab is quite new. Give us a sense of how you in clinical practice decide between the two potential options here. Dr. Vamsi Velcheti: Yeah, I think that's the big challenge. I think these are two independent strategies that have evolved through the phase 3, and both of them have demonstrated overall survival benefit. So, the way I think about this is in three dimensions, right? Like, the disease biology, the patient priorities, and feasibility of care delivery. So, when I talk about the disease biology, you know, the mechanism is very different, and MET is a very dominant driver of disease in EGFR-altered patients and it's a significant mechanism of resistance, acquired resistance to TKIs. So, certainly I think there's a patient population that could benefit from a MET-directed therapy up front. However, we don't have great data to kind of really demonstrate how using amivantamab in the front line is going to change that. And are there like perhaps like some patients who we could identify who would benefit from such a strategy? Very recently, there have been some approvals in the second-line setting in lung cancer, not in the EGFR space, but like in generally in lung cancer, with the MET ADCs, and those drugs are approved with a companion diagnostic, which requires MET IHC testing. So, what has happened, at least in large academic practices and also I think in the community now, they have been checking for MET IHC expression more routinely in lung cancer. What we have been doing in our institution is we have been doing MET IHC as a reflex for all patients with EGFR, not just EGFR, but all non-small cell lung cancer patients. What that has done is now, like, we have been increasingly testing patients with EGFR for MET. And there's clearly a subset of patients who have de novo MET expression and a high MET expression. And those patients, I've been kind of like preferentially treating them with the MARIPOSA regimen. But again, I have to caution the audience that we still don't have data that MET IHC is going to help us make those decisions, whether it's better than like a FLAURA2 regimen. But however, in the second-line setting in the CHRYSALIS trial, we know that MET is a very powerful predictor of response to amivantamab. We really need more data there, but that's what I have been doing in my practice. But also, there's a lot of patient preference here. Like, there are some patients who don't want chemotherapy, and they want a non-chemotherapy approach. So, certainly there are some patients who prefer to have amivantamab. And now with the amivantamab, the subcutaneous version, the infusion reactions and the logistics of actual administration of amivantamab are more favorable with the subcutaneous approval. So, those are some of the elements that we need to take into account. Dr. Monty Pal: Well, I want to hone in on that because this subcutaneous administration route has been a big debate that I've seen on social media. Tell us, how much easier does it actually make the amivantamab experience? Does it cut down on the rash? Is it just infusion reactions? What's been your clinical experience? Vamsi Velcheti, MD: So, the subcutaneous administration of amivantamab has definitely improved the infusion reaction issue. Very rarely patients have infusion reaction now with the subcutaneous injections. And also, the infusion time is much, much shorter. Like we don't need a lot of infusion time, which is sometimes a challenge in busy infusion clinics. We need to take that into account. As far as the impact of the subcutaneous formulation on dermatological toxicity, we haven't really seen significant difference in terms of the intensity or rates of dermatological toxicity with subcutaneous. The benefits are really with the infusion reaction, the ease of administration. And interestingly, in the PALOMA trial, it also seems to be, even though this was not the primary endpoint of the study, there seems to be some suggestion that the subcutaneous amivantamab seems to have improved OS compared to the IV amivantamab. We don't really understand why, but that's a finding from the trial that's very intriguing. Dr. Monty Pal: That is really fascinating. I'm kind of curious to see how that's going to pan out. I'm going to shift gears a little bit here. And, you know, as we sort of close, I wanted to talk a little bit about biomarkers. I mean, this is obviously not a lung cancer-specific issue. It's something we think about across the board. But what I will say is that there are certain commonalities, and in bladder cancer, we think a lot now about ctDNA. But you've been way ahead of the game in lung cancer. Tell us how you guys use ctDNA, maybe both from the standpoint of monitoring for mutational status, but if you can, maybe offer some insights into some of these new MRD tests that are available too. Dr. Vamsi Velcheti: Yeah, it's rapidly evolving. Certainly, I think in the lung cancer space, you know, this has really kicked off in the lung cancer space with incorporating ctDNA into the workflow. Of course, you know, like baseline evaluation, we still kind of heavily rely on tissue genomic sequencing. But as you know, with targeted therapy, a lot of these patients have disease that evolves over time, and changes in terms of mutational pattern driving acquired resistance is a major issue across different molecular subtypes. And especially so in EGFR, when there are certain actionable opportunities associated with that transformation. So, we need to kind of have like a longitudinal snapshot of how we monitor these patients. So, the ctDNA has come to be like a tool that has now come to the forefront of clinical workflow, and almost all my patients who are having disease progression have ctDNA for kind of evaluating for resistance and informing treatment decisions, especially in EGFR. But having said that, there are a lot of challenges in terms of using ctDNA as a tool for monitoring. There are a lot of different types of assays and different platforms, and being able to use this as a quantitative tool that would be used along with the CT scans that we routinely use in clinical practice has been a challenge. And I think I would love to hear your perspectives as well, Monty, about how you're thinking about that in bladder and other disease contexts. But having said that, I think there's a lot of opportunity to incorporate ctDNA and MRD assays into clinical decision-making. Right now, in terms of clinical trials and clinical development, there have been some very interesting trials that are currently ongoing, especially in the EGFR space. We know that patients who clear ctDNA, based on some retrospective data and also like some retrospective-prospective data from trials that have already read out, that patients who clear ctDNA early with target therapy tend to do much better. They have a longer durability of response. There may be a subset of patients who have, even though they're having radiographic response, they have persistent ctDNA after a certain time point of initiation of targeted therapy. Those patients may require escalation of therapy. We don't yet know. I can't recommend that as a standard right now because we don't have clinical evidence to support that. But however, some of the clinical trials, like the ELIOS trial that's being done right now, that's actually completed enrollment, we'll hopefully see the results very soon. So, there is an emerging thought that instead of intensifying treatment for all patients with EGFR, there may be a population that may be just fine with frontline osimertinib monotherapy and introducing the intensification strategy at the time of emergence of MRD or progression on ctDNA before radiographic progression. So, there are a lot of adaptive molecular response criteria that we are kind of exploring in clinical trials that could inform how the future is going to look like for EGFR and other perhaps targeted therapies as well. So, it's fascinating, and I think there's a lot of opportunity there. Dr. Monty Pal: You know, you asked for my perspective. I actually think that what you highlighted there is the most interesting opportunity for ctDNA: the ability to de-escalate therapy. In terms of drug development, we've done so much to bring new therapies to patients, and now it's a bit of an embarrassment of riches, but the downside is that I feel like we tend to overtreat a lot of patients in the clinic. So, I definitely view MRD, you know, some of these other ctDNA techniques with methylation and so forth that may not be sort of tumor-dependent or bespoke could be incredibly, incredibly helpful. You touched on sort of the future, right, in this last section here with biomarkers. But give us a sense now in terms of novel drug therapies in the EGFR space. What are you most excited about moving forward in 2026 and beyond? Dr. Vamsi Velcheti: Yeah, I think there's a lot going on in this space, and not just this space, but across lung cancer and others as well. Like looking at the next generation of targets for ADCs. And I think a lot of these have to do with…so far in the drug development space, as you know, the improvements in clinical outcomes has been very incremental. So, we really need to make that big leap. And I think the big leap is not going to come from, in my opinion, from the next ADC, but it's going to come from how we tailor treatments and how we monitor disease better and how do we kind of incorporate the next treatment earlier and not wait for the radiographic progression. So, there's a lot of opportunity there to integrate biomarkers and dynamic biomarkers into clinical trial design and incorporating the recent advances in terms of drug design. You know, we have a lot of assets in the EGFR space, the next-generation EGFR inhibitors that are kind of designed with resistance in mind and rational combination, knowing when to introduce those combinations is also equally important. So, there's a lot going on, really exciting times to be in drug development. The one thing that I really hope will come to the forefront in drug development, not just for lung cancer, but all disease groups, is to kind of really be thoughtful about how we incorporate these really cool molecular monitoring tools and creating a composite score with imaging to be able to like really design the next generation of clinical trials. Dr. Monty Pal: You're so spot-on with that. I definitely think that we're getting to this point where, you know, we could think about the next BiTE, the next CAR-T, the next ADC. But, you know, maybe it's time for us to start really honing in on appropriate applications of these drugs, honing in on the right dose and what have you, because I definitely see some issues there.  Vamsi, this has just been terrific. I really want to thank you so much for sharing your fantastic insights with us today on the ASCO Daily News Podcast, and I really appreciate all your efforts to move the field of lung cancer forward. Dr. Vamsi Velcheti: Thanks, Monty. I really enjoyed the conversation. Dr. Monty Pal: Yeah, this was terrific.  And thanks to our listeners as well. If you value the insights that you hear from the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Follow today's speakers:     Dr. Monty Pal   @montypal  Dr. Vamsi Velcheti @VamsiVelcheti Follow ASCO on social media:          ASCO on X    ASCO on Bluesky         ASCO on Facebook          ASCO on LinkedIn          Disclosures:       Dr. Monty Pal:      Speakers' Bureau: MJH Life Sciences, IntrisiQ, Peerview     Research Funding (Inst.): Exelixis, Merck, Osel, Genentech, Crispr Therapeutics, Adicet Bio, ArsenalBio, Xencor, Miyarsian Pharmaceutical     Travel, Accommodations, Expenses: Crispr Therapeutics, Ipsen, Exelixis   Dr. Vamsi Velcheti:   Honoraria: Galvanize Therapeutics  Consulting or Advisory Role: Bristol-Myers Squibb, Merck, AstraZeneca/MedImmune, GSK, Amgen, Taiho Oncology, Novocure, Regeneron, Takeda, Janssen Oncology, Picture Health Research Funding (Inst.): Genentech, Trovagene, Eisai, OncoPlex Diagnostics, Alkermes, NantOmics, Genoptix, Altor BioScience, Merck, Bristol-Myers Squibb, Atreca, Heat Biologics, Leap Therapeutics, RSIP Vision, GlaxoSmithKline

This Special Episode on Atrial Fibrillation covers: Cardiology this Week: A concise summary of recent studies Atrial fibrillation burden: clinical relevance of a new outcome Pulsed field ablation: game changer? Drug treatment following atrial fibrillation ablation Spotlight: Holiday Heart Syndrome Host: Rick Grobbee Guests: Rick Grobbee, Konstantinos Koskinas, Jason Andrade, Arian Sultan, Michiel Rienstra Want to watch that special episode? Go to: https://esc365.escardio.org/event/2549 Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Jason Andrade, Yasmina Bououdina, Rick Grobbee and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada.  Michiel Rienstra has declared to have potential conflicts of interest to report: consultancy fees from Bayer (OCEANIC-AF national PI) , InCarda Therapeutics (RESTORE-SR national PI), Novartis to the institution. Speaker fee from Daiichi-Sankyo, Pfizer to the institution. Unrestricted research grant from the Dutch Heart Foundation and is conducted in collaboration with and supported by the Dutch CardioVascular Alliance, 01-002-2022-0118 EmbRACE. Unrestricted research grant from ZonMW and the Dutch Heart Foundation; DECISION project 848090001. Unrestricted research grants from the Netherlands Cardiovascular Research Initiative: an initiative with support of the Dutch Heart Foundation; RACE V (CVON 2014–9), RED-CVD (CVON2017-11). Unrestricted research grant from Top Sector Life Sciences & Health to the Dutch Heart Foundation (PPP Allowance; CVON-AI (2018B017). Unrestricted research grant from the European Union's Horizon 2020 research and innovation programme under grant agreement; EHRA-PATHS (945260). This research is funded by the Dutch Heart Foundation and is conducted in collaboration with and supported by the Dutch CardioVascular Alliance, 01 -002 -2022 -0118 EmbRACE.  Emma Svennberg has declared to have potential conflicts

Celeste Warren spent 28 years at Merck, where she rose to become Vice President and Chief Diversity and Inclusion Officer. Since retiring from Merck, she founded Celeste Warren Consulting, where she continues to advise organizations on leadership, culture, and inclusion. Together with her two children, she also co-founded Destination STEM, a nonprofit dedicated to supporting students pursuing careers in science, technology, engineering, and mathematics.Celeste has been widely recognized for her work in diversity and inclusion, and she is the author of a new book titled The Truth About Equity: What It Really Is, What It Isn't, and Why Everybody Wins When They Get It Right.In our conversation, Celeste shares the personal story that first shaped her perspective on equity and leadership, growing up as the daughter of the first Black teacher, principal, and superintendent in his school district. We also explore her unexpected path into human resources, the lessons she learned about leadership early in her career, and why servant leadership and situational leadership are so critical for building successful teams.Finally, we spend time breaking down what diversity, equity, and inclusion actually mean in practice, why the concepts are often misunderstood, and how leaders can approach them in a thoughtful and practical way inside their organizations.Contact Dino at: dino@al4ep.comWebsites:CRWDiversity.comal4ep.comAdditional Guest Links:Contact at:LinkedIn: linkedin.com/in/celestewarrenllcInstagram: @crwdiversityYouTube: youtube.com/@celestewarren-equityAuthentic Leadership For Everyday People / Dino CattaneoTruth About Equity Book on Amazon: mybook.to/TruthAboutEquityDino on LinkedIn: linkedin.com/in/dinocattaneoPodcast Instagram – @al4edp Podcast Twitter – @al4edpPodcast Facebook: facebook.com/al4edpMusicSusan Cattaneo: susancattaneo.bandcamp.com

Join us in community:  Women Connected in Wisdom Community Listen to past episodes: https://womenconnectedinwisdompodcast.com/ Glo from head to toe by joining the shealo glo glo club at www.shealoglo.com ! Stillpoint: A Self-Care Playbook for Caregivers Join Christine at an event! Like & Subscribe to get notifications of when we are live: Women Connected in Wisdom Instagram Women Connected in Wisdom on Facebook **Women Connected in Wisdom on YouTube** Resources & What we are up to   How do you transform a deep personal legacy into a creative force for good? Ksenia J. Merck shares how intellectual wellness and art can help us navigate love and existence.   In this week's episode of Women Connected in Wisdom podcast, we welcome our guest, Ksenia J. Merck — an architect, artist, and author who has spent four decades shaping the physical world through large-scale airport programs. Today, she is shaping the world of storytelling as the creative force behind Ghost Flower, a science fiction novel written by her late husband, William F. Merck II, which she illustrated and published posthumously.   We explore the Intellectual Wellness dimension, discussing how Ksenia used her creative skills to honor her husband's legacy while expanding her own whole-self growth. From her architectural background to her work on the Ghost Flower Companion Journal, Ksenia shares how deep reflection, thought-provoking quotes, and art can help us process the mysteries of life.   Women Connected in Wisdom is a community-driven podcast hosted by Christine and Shannon, where we explore the 8 Dimensions of Wellness to help you live a more balanced, purposeful life.   Connect with Ksenia J. Merck: Website: https://www.merckiipress.com Instagram: @Merck2Press Somethings we talked out: Ghost Flower - all versions including audio Your Brain on Art:  How Art Transforms Us

As the weather begins to warm up and insects return, ranchers will again face the challenge of managing insect pressure as well as concerns associated with complications caused by these tiny nuisances.Our host, Shauna Hermel, was joined at CattleCon 2026 by Deana Hardee, veterinarian with Merck Animal Health, and Megan Silveira, managing editor with the Angus Journal, regarding New World screwworm, cattle fever ticks, the Asian Longhorned Tick and a conditionally approved product from Merck that could help protect U.S. cattle from future threats. Thank you to Superior Livestock for their sponsorship of this episode.Have questions or comments? We'd love to hear from you!Find more information to make Angus work for you in the Angus Beef Bulletin and ABB EXTRA. Make sure you're subscribed! Sign up here to the print Angus Beef Bulletin and the digital Angus Beef Bulletin EXTRA. Have questions or comments? We'd love to hear from you! Contact our team at abbeditorial@angus.org.

If you've ever questioned whether your loved ones are still with you after they're gone, Episode 410 of Grief and Happiness is not to be missed. Architect and artist Ksenia J. Merck shares how losing her husband Bill led her to complete his lifelong dream — finishing his science fiction novel Ghost Flower and authoring its companion journal. Through art, philosophy, and soul-searching questions about purpose and time travel, Ksenia shows how grief can become the unexpected catalyst for your greatest creative work.In This Episode, You Will Learn:(00:55) Ksenia's introduction as architect, artist, and author(01:49) The story behind Ghost Flower and Bill's hospital bed sketch(04:04) Feeling her husband's presence through the creative process(04:38) Inside the Ghost Flower Companion Journal and how it works(07:14) Would you time travel to save humanity? The book's soul-searching questions(11:02) Purpose as one of the most powerful tools for grief(12:35) How this project pulled Ksenia through her darkest chapter(14:22) Emily's journey from caregiving and loss to purpose-driven living(16:49) Turning the most painful experience of your life into something meaningful(19:29) Soul contracts, twin flames, and why this project was always meant for her(21:32) The oak tree story — and why Ksenia believes Bill guided it downKsenia J. Merck, AIA, NCARB is an architect, artist, and author with over four decades in the industry and a Bachelor of Architecture from Virginia Tech. By day, she serves as a Program Manager for large-scale Airport Capital Programs in Orlando; by calling, she bridges architectural precision with visionary artistry through her sketchbook and canvas. Fueled by a deep love of art history, travel, and the cosmic mysteries of the universe, her work explores themes of life, the afterlife, and the wonders that lie beyond. Her latest illustrations appear in Ghost Flower, a science fiction novel by her late husband William F. Merck II — for which she painted the cover and authored the companion journal. Originally from Arizona, she now calls Florida home.In this episode, Ksenia opens up about how grief became the doorway to profound purpose. After losing her husband Bill in March 2024, she channeled her loss into completing his lifelong dream — painting the cover of his science fiction novel Ghost Flower and authoring the Ghost Flower Companion Journal, a collection of illustrations and philosophical questions designed to deepen the reader's experience of the book. She shares how the project gave her direction at her most vulnerable, and how she believes Bill has remained a guiding presence every step of the way. Together, Ksenia and Emily explore the power of soul contracts, twin flames, and the idea that grief — when met with openness — can become the foundation for a meaningful new chapter.Connect with Ksenia J. Merck:WebsiteInstagramLinkedInFacebookLet's Connect: WebsiteLinkedInFacebookInstagramTwitterPinterestThe Grief and Happiness AllianceBook: Emily Thiroux Threatt - Loving and Living Your Way Through Grief Hosted on Acast. See acast.com/privacy for more information.

Second week of March, what'd you miss in vet med?FDA approves Merck's NUMELVI — first second-gen JAK inhibitor for dogsPE firms struggling to exit pandemic-era vet deals (Encore, CareVet, and Blue River hit the market)InnoCan gets third FDA fee waiver for CBD pain injection in dogsPetSmart + Healthy Paws expand insurance partnershipPetco Love hits 4 million free vaccinesHelpful links:The Bird Bath substackVRCE - The Veterinary Profession's #1 CSR Development Program2026 Animal Health Summit Emerging Company ApplicationTikTok - Is it Pet Smart or Pets Marks?

Dr. Pedro Barata and Dr. Kathryn Schmitz discuss evidence-based exercise oncology programs, how to incorporate exercise into cancer care and connect the right patient to the right program, and ultimately build a culture of exercise in oncology. TRANSCRIPT Dr. Pedro Barata: Hello, and welcome to By the Book, a podcast series from ASCO that features compelling perspectives from authors and editors of the ASCO Educational Book. I'm Dr. Pedro Barata. I'm a medical oncologist and a clinical trialist at the University Hospital Seidman Cancer Center and an associate professor of medicine at Case Western Reserve University in Cleveland, Ohio. I'm also happy to serve as a deputy editor for the ASCO Educational Book. Today, we'll be talking about exercise. We have plenty of evidence that exercise benefits symptoms, improves the quality of life of patients, and actually has been shown to reduce risk of recurrence of cancer but also improve survival. And I think that's increasingly clear as data emerges. Today, I'm delighted to be speaking to Dr. Kathryn Schmitz. She's a leading expert on integrating exercise into cancer care. Dr. Schmitz serves as the deputy director of the University of Pittsburgh Hillman Cancer Center and also a professor of hematology-oncology at University of Pittsburgh Medical School. She's the senior author of a fantastic article in the ASCO Educational Book that's titled "Implementation Science as the Secret Sauce for Integrating Exercise Screening and Triage Pathways in Oncology." She also led a really compelling piece that just got published in JCO titled "If Exercise Were a Pill, We'd All Prescribe It to Patients With Cancer. But It's Not" So I'm thrilled to have Dr. Schmitz joining us today and helping us explore evidence-based exercise oncology programs, how to incorporate exercise into cancer care, and also how to connect the right patient to the right program.  So with that, welcome, Dr. Schmitz. Thank you so much for taking the time to chat with us. Dr. Kathryn Schmitz: Thank you for the opportunity. Dr. Pedro Barata: One of the highlights of ASCO last year and practice changing, in my opinion, data out of The New England [Journal of Medicine] is called the CHALLENGE trial. It did provide high level evidence that a structured, supervised exercise program could improve both disease-free survival and overall survival. This is a study in the GI world, but I think it got a lot of attraction and attention beyond the GI world, across solid tumors, really. Could you give us a little brief recap of that trial and what have you seen as being the impact in practices around oncology? Dr. Kathryn Schmitz: So, CHALLENGE was very exciting. Prior to CHALLENGE, there were any number of observational studies that indicated that there was a relationship between being more physically active and reduced recurrence and improved overall survival for colon cancer in particular. You know, notably, in 2006, Jeff Meyerhardt published two papers in the same journal, of the same issue of JCO, showing very, very similar data from two very large studies. And those were studies number five and six in this area. You know, there's a lot of evidence observationally, but we don't generally change clinical practice on the basis of observational data. So, we were all waiting very impatiently for the results of the CHALLENGE trial. And it was very exciting to be in the front row when the results were reported out and to be part of the group with a standing ovation for the authors when it was presented. To summarize, 889 colon cancer patients, stage II and III, were randomized into either a structured exercise program or a health education control comparison group and followed for an average of 7.9 years. And the structured exercise group had a 27% reduced risk of recurrence and a 38% improvement in overall survival. One of the things that's really notable about this is that what we typically expect is that when we go from the observational literature to the clinical trial literature, that we expect effects to go down. We expect to see a larger effect in the observational than in the RCT land, and that did not happen here. We actually see an effect that matches what we've seen in observational literature, which is really, really exciting.  And, you know, one of the reasons why this has been so exciting across not just GI but other cancers is the notable finding of a reduced risk of second primaries. So, they only observed two breast cancer second primaries in the treatment group and 12 in the comparison group. And overall, they reduced the second primaries occurrence, hazard ratio was 0.5, a 50% reduction of second primaries, which is just remarkable. It really got everybody very, very excited. And now the big question, of course, is, all right, how do I do this? How do I make this happen?  The thing to note is that what they did in CHALLENGE is probably not doable in your clinic tomorrow. It's a heavy intervention. The number of touchpoints from staff is extensive, and the amount of time needed from staff for the coaching and supervised exercise is extensive as well. The criteria for getting people into the program required that people go through a series of blood tests and imaging tests that would just simply not be possible for the average community oncologist. So I'm guessing that you're going to ask me some questions about how we do this. Dr. Pedro Barata: Right. That's a fantastic segue. That's exactly right. Walk us through maybe starting by, what does that mean? Dr. Kathryn Schmitz: The first thing to say is I have to go back to the observational literature. And the observational literature shows really compellingly that we have a strong reduction of breast cancer recurrence and mortality from being more physically active, prostate cancer recurrence and mortality, and colon cancer recurrence and mortality. I find it very difficult to believe in this day and age, in our current environment, if you will, that we are ever going to have the equivalent of CHALLENGE for prostate or for breast cancer. There is an ongoing study in prostate that's led by some Australian researchers, but I just don't think that it's likely that we're going to mount something similar for another tumor site. We have tremendous correlative data that indicates that there are a number of biomarkers and biological pathways through which breast, colon, and prostate cancer would be reduced in recurrence if people were more physically active. And so, there is really, from my thinking, very little to state that it would be just a colon cancer effect. And so this is something we probably can enact in more than just the colon cancer community, overall, which is great news, and it makes it easier for us to be able to enact this type of programming. Dr. Pedro Barata: One of the things that comes up perhaps often is, if I were the leader of the cancer center and were to incentivize the different care teams to implement an exercise program at each level: GI team, GU, breast, thoracic, etc. How do we do that? Dr. Kathryn Schmitz: So, I want to give you an analogy. You're a medical oncologist, and you prescribe your patients chemotherapy. Now, just imagine, if you will, what would happen and how likely it would be for your patients to get chemotherapy if there was no chemoinfusion suite. If the chemoinfusion suite disappeared tomorrow and you were to tell your patients, "Go get some chemotherapy," what proportion of those patients do you think would go find all of the equipment necessary and all of the drugs necessary and understand how to dose the chemotherapy for themselves and get that all done? Very few people would do it. So with exercise, why would we be surprised then that our patients don't actually do a whole lot if we just simply tell them to go get some exercise? Exercise is a medicine. It is effective like a medicine. We've shown this through the CHALLENGE trial and many other correlative studies and an ocean of observational data as well. So the question is, how do we build the infrastructure that is necessary in order for your patients to do this? So the very first thing that has to happen is that somebody has to tell the patient to exercise. We currently do not have a culture of exercise in oncology. We do in heart disease. If you ask the average person on the street, "Is exercise good for your heart?" Anybody with an eighth-grade education is going to say, "Yes, of course," because the American Heart Association has done an amazing job telling everybody that exercise is good for your heart. But what has ASCO done, frankly? Can I be that bold? What has ASCO done to tell patients that they should be exercising during and after their cancer treatment? I'm not sure that I know more than a guideline. There is a guideline, and that's great. And the guideline is very helpful, but I'm not sure that patients know that there's a guideline. In fact, I can tell you that patients don't know that there is a guideline. So, you know, making sure that there's a paradigm shift in the country that says exercise is good for patients during and after their cancer treatment is the first step. The second step is getting a medical professional to say something to the patient about the exercise. And I'm very careful with the two words that I just chose: medical professional. I do understand medical oncologists are very busy. I understand that there's a whole lot to say in that 15 minutes when you're with the patient. And so maybe it isn't the medical oncologist. Ideally, it would be, but I get it that there's limited time. So it could be a nurse practitioner, it could be a nurse, there could be a social worker, it could be somebody else on the team that says, "Hey, you know, we want you to do an exercise program. We want to connect you to an exercise program." And then there's what is the program itself? You know, I'm very interested in this happening across the entire country. And so I've been working with the leadership of the Commission on Cancer on the question of, well, how would you do this in community oncology? You know, it's not enough to do it in academic medicine, but how do you do this in community oncology? And you can't expect that every community hospital is going to build a gym for their cancer patients. That is just not reasonable to do. So, we start to try to figure out some phone counseling. Could we give people Fitbits and follow them? Could we use technology to help us? Are there telehealth opportunities for us to do? Are there apps that have been built? In fact, there is a [free] app called Cancer Exercise that's on, you know, all of the platforms and available to patients. So there are programs. I've developed a directory of over 2,000 programs that exist across the country for exercise oncology that patients can find, medical oncologists can find.  So there are a lot of people trying to figure out how best to get the information to medical oncologists and other medical professionals so that they can have an 'easy button' to be able to connect their patients to existing programming so that you don't feel like you have to build a whole new program. Dr. Pedro Barata: If I don't have the resources around me, what would be your advice for the care team or for the providers that might not have that available at their site? Where do they start? Who do they reach out to? Who should they be looking at to get more information on how to set it up? Dr. Kathryn Schmitz: I lead an international consortium called Moving Through Cancer. You can find us at movingthroughcancer.org. That's where you'll find the map of all of the programs across the country and the directory. We actually have a triage tool that sits at the front of the directory that allows people to discern what type of exercise they're safe to do. We do recognize that, you know, the 80-year-old that fell last week doesn't need the same program as the 35-year-old that was playing pickleball the day before diagnosis. So, you know, there are different kinds of programs for people at different levels of acuity. We're happy to be helpful to folks to help them set up programs.  But the number one thing is to really be very aware of the power of saying something about doing exercise, just simply the power of saying, "I want you to be moving." Because frankly, I don't think anybody listening to this would disagree, no one benefits from sitting on the couch all day, no one. No one, no one. It doesn't matter how acute their medical issues are. We get people out of bed. We try to move people even when they're in the hospital. So I think saying something is huge. And then, if you can, applying a triage tool, if you can get something embedded within your clinical flow so that you can understand who it is that needs to go to physical therapy as opposed to who's ready for an exercise program. Those are the two things. So triage and referral is kind of step one. And if you can get that done, the rest will fall into place. Dr. Pedro Barata: This is really powerful message, where one, awareness of the care teams. Number two, bring it up to the patient. And then working on the referral, triage and referral process. That's fantastic. Another aspect that comes up quite a bit is like, "Look, this is great, but we have a system that relies on payers to make things happen, or at least to get them approved." And that can be very different or heterogeneous. The coverage can be different. Sometimes already going through a system programs for interventions, therapeutic interventions, let alone probably the insurance is not going to cover that. Is that true? Is it not true? How do you walk through the different insurance supports, perhaps, depending on where you're practicing? Dr. Kathryn Schmitz: You've just hit on the hot button. I've been working on this issue for about nine years now, trying to figure out using efforts to talk to CMS and see if we can get third party payer coverage going. We were making good progress there, and there was a change of administration and a new focus on "Make America Healthy Again," the MAHA movement. And, you know, CMS is really no longer interested in one-off national coverage determination. They instead, they want to know, "How do we make exercise happen for every American over 65?" And my question is, "Well, wait a minute, cancer patients are not just older patients. There's a lot going on there. They need something special." So I've been working on that. It's been working with accrediting bodies for policy with a little p. Very proud of the work that I've done in collaboration with the National Accreditation Program for Breast Centers, trying to get standards to get exercise referrals for breast patients. And I'm currently holding my breath to see whether the CoC is going to try to make some forward motion in this area as well, crossing all period appendages, waiting for news there. So it's not paid for unless it's done by a physical therapist. And, you know, there's published evidence and I have plenty of evidence from UPMC as well, that people don't really want to go to the physical therapist for this. I'm not saying physical therapists aren't great. Physical therapists are great, and there are people who really need to go to physical therapy, and we try hard to get those patients connected. But for the patients that are ready for something more than physical therapy, we really have an uphill battle to try to figure out what insurers are willing to pay for and what the return on investment is.  One of the challenges with the return on investment is that the timeline, time course for return on investment for American insurers is about one year. And I'll remind you that the time course for return on investment for CHALLENGE was 7.9 years. So we have a mismatch there. So we're trying to figure out if we can produce the evidence to show that there is an improvement in unplanned health care utilization. We have documented that for breast cancer. We're working on it for other cancers. If we can document that it is worthwhile to the insurer to pay for these programs, then I believe that they will pay for them. You know, my conversations are very positive with UPMC, which is a very large insurer and a large health plan. We're slowly working our way towards the middle, where there's a program that they can pay for and a program that is efficacious. That's the puzzle we're trying to solve for right now. Dr. Pedro Barata: This has been wonderful and super helpful. Before we wrap it up, is there anything else you would like to share with our listeners? Dr. Kathryn Schmitz: I want to make sure that your audience is aware that there are a variety of ways that exercise oncology is practiced. The program that most oncologists will be familiar with is LIVESTRONG, which is a program at the YMCA. It's a free program. At one point, there were over 800 locations across the U.S. They have contracted since COVID, probably because of COVID. So they still do exist but imagine, if you will, telling your patients that chemo is only available Tuesdays and Thursdays at 7:00 p.m. It would be difficult for patients to get there and get the chemotherapy. The same thing is true for the LIVESTRONG program. It's a fantastic, fantastic program for people who are able to get there, but that's one option. Another option for patients is there are a variety of online opportunities. I'll call out 2Unstoppable for women's cancers. It's literally the number 2Unstoppable.org. It's a free program available to women with cancer to have live, small group training programs. And they're based in Virginia, but they have programs all over the country. And then finally, I just want to overemphasize the app, the Cancer Exercise app. It's literally called Cancer Exercise in the app store. And that is a super duper easy button, very comprehensive, developed by a nurse scientist, Anna Schwartz. And then there are a variety of books. I wrote a book called Moving Through Cancer. There's a new book out [MyExerciseMedicine for Cancer] by Dr. Rob Newton as well, who's an Australian author. And there are certifications for exercise professionals that folks can look into as well through the American College of Sports Medicine. Dr. Pedro Barata: Dr. Schmitz, this is fantastic. Thank you for sharing those great insights with us. Super, super helpful. Thank you for taking the time. Dr. Kathryn Schmitz: Thank you so much. Dr. Pedro Barata: Thank you to our listeners for your time today. Remember, you'll find links to Dr. Schmitz's fantastic Educational Book as well as the JCO articles in the transcript of this episode. I'll invite all of you to go and read. And we'll also include a link to Dr. Schmitz's book titled Moving Through Cancer: An Exercise and Strength Program for the Fight of Your Life, which empowers patients and caregivers in simple five steps.  So with that, please join us again next month on By the Book for more insights on key advances and innovations that are shaping modern oncology. Thank you very much for your attention. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Follow today's speakers:           Dr. Pedro Barata    @PBarataMD     Dr. Kathryn Schmitz @fitaftercancer Follow ASCO on social media:           @ASCO on X (formerly Twitter)           ASCO on Bluesky          ASCO on Facebook           ASCO on LinkedIn           Disclosures:        Dr. Pedro Barata:    Stock and Other Ownership Interests: Luminate Medical    Honoraria: UroToday    Consulting or Advisory Role: Bayer, BMS, Pfizer, EMD Serono, Eisai, Caris Life Sciences, AstraZeneca, Exelixis, AVEO, Merck, Ipson, Astellas Medivation, Novartis, Dendreon    Speakers' Bureau: AstraZeneca, Merck, Caris Life Sciences, Bayer, Pfizer/Astellas    Research Funding (Inst.): Exelixis, Blue Earth, AVEO, Pfizer, Merck     Dr. Kathryn Schmitz: Patents, Royalties, Other Intellectual Property: Fees from the educational program developed by Dr. Schmitz that is now offered through Klose Training and Consulting.

Dr. Aly-Khan Lalani and Dr. Christopher Wallis also discuss the RAMPART trial, LITESPARK-011, and the K-COMPASS model. This final recap episode highlights how evolving adjuvant strategies and combination sequencing are reshaping the kidney cancer landscape. Be sure to listen to Episodes 35 and 36 for the full ASCO GU recap, covering key updates in prostate and bladder cancer!The View on GU with Lalani & Wallis integrates key clinical data from major conferences and high impact publications, sharing meaningful take home messages for practising clinicians in the field of genitourinary (GU) cancers. Learn more about The View on GU: theviewongu.caThis podcast has been made possible through unrestricted financial support by Pfizer, Tolmar, AbbVie, Astellas, Eisai, Ipsen, Merck, Bayer, TerSera.

Dr. Aly-Khan Lalani and Dr. Christopher Wallis discuss practice-changing data in non-muscle invasive and muscle-invasive bladder cancer, including perioperative strategies,bladder-sparing approaches, and emerging targeted therapies. Don't forget to watch or listen to Episode 35 and Episode 37 for updates on prostate and kidney cancer!The View on GU with Lalani & Wallis integrates key clinicaldata from major conferences and high impact publications, sharing meaningful take home messages for practising clinicians in the field of genitourinary (GU) cancers. Learn more about The View on GU: theviewongu.caThis podcast has been made possible through unrestricted financial support by Pfizer, Tolmar, AbbVie, Astellas, Eisai, Ipsen, Merck, Bayer, TerSera.

Dr. Aly-Khan Lalani and Dr. Christopher Wallis also highlight Canadian-led innovation in the GUNS trial and early data from the PAnTHA study, and discuss how Prostate Cancer Working Group 4 may redefine trial design. Episode 35 is the first of three ASCO GU recap episodes, so don't miss Episode 36 on bladder cancer and Episode 37 on kidney cancer!The View on GU with Lalani & Wallis integrates key clinical data from major conferences and high impact publications, sharing meaningful take home messages for practising clinicians in the field of genitourinary (GU) cancers. Learn more about The View on GU: theviewongu.caThis podcast has been made possible through unrestricted financial support by Pfizer, Tolmar, AbbVie, Astellas, Eisai, Ipsen, Merck, Bayer, TerSera.

Just when you thought you'd heard everything about virtual fence, another podcast episode comes along. But Dr. Flavie Audoin, University of Arizona Cooperative Extension rangeland specialist, may be one of the most importance "voices" to listen to on the strengths and weaknesses of virtual fence and animal geolocation technologies. She has been in the middle of much of the early vendor comparison work as well as experimental research on animal physiology considerations and environmental applications for remote animal location detection and control. Listen to this interview to learn about the mechanisms of virtual fence options, a comparison and contrast of features on offer, and current research on graziers can better manage wild, open spaces with a back-to-the-future approach to modern herding. The Art of Range Podcast is supported by the Western Extension Risk Management Education Center, Vence (a subsidiary of Merck), and the Idaho Rangeland Resources Commission. Music by Lewis Roise. Visit the episode page at https://artofrange.com/episodes/aor-178-flavie-audoin-animal-geolocation-and-virtual-fence-technologies for the transcript of this interview and links to resources mentioned in this episode.

Dr. Monty Pal and Dr. Andrea Apolo discuss practice-changing studies and other novel approaches in bladder, kidney, and prostate cancers that were presented at the 2026 ASCO Genitourinary Cancers Symposium. TRANSCRIPT Dr. Monty Pal: Hello and welcome to the ASCO Daily News Podcast. I'm your host, Dr. Monty Pal. I'm a medical oncologist, professor and vice chair of academic affairs at the City of Hope Comprehensive Cancer Center in Los Angeles.  And today is super exciting, we're highlighting key abstracts that were presented at the 2026 ASCO GU Cancers Symposium, and I'm just delighted to be joined by the chair of this year's meeting, who is also a dear friend, Dr. Andrea Apolo. Dr. Apolo serves within the Center for Cancer Research at the NCI as head of the Bladder Cancer Section, and she is also acting deputy chief of the Genitourinary Malignancies Branch.  Welcome, Andrea, it is so great to have you on the podcast. Dr. Andrea Apolo: Oh, thank you so much for having me. What a great ASCO that we had, it is really exciting, lots of really great data. So I look forward to chatting about it. Dr. Monty Pal: Excellent. And you know, our full disclosures are available in the transcript of this episode in case our listeners want to have a peek.  The theme of this year's GU meeting was "Patient-Centered Care: From Discovery to Delivery." I love that theme. And really, this is one of the most competitive meetings out there, more than 850 abstracts being presented on high-impact science. Andrea, I just wanted to get right into it and dive into what I think we both felt were some of the most exciting abstracts of the meeting.  And the first of those is one that I know is near and dear to your heart, being a bladder cancer expert yourself, and that is the KEYNOTE-B15 study presented by Matt Galsky. Can you give us a flavor for what that study entailed and some of the key results? Dr. Andrea Apolo: Yeah, I think this was kind of the missing study that we have been waiting for since we saw the EV-302 data in metastatic disease in the frontline setting. We wanted to know how well this combination would work in muscle-invasive bladder cancer patients. And we saw half of that puzzle, you can say half of the piece of the puzzle, when we saw the data at ESMO, the EV-303 data in patients that were cisplatin-ineligible. And then now we are getting the full story with patients that are platinum-eligible, cisplatin-eligible, with the EV-304 data. So that study randomized patients to receive chemotherapy, so different than the EV-303 where the patients were randomized just to receive the radical cystectomy. These patients were randomized to receive neoadjuvant EV plus pembro and then adjuvant EV plus pembro versus neoadjuvant gemcitabine and cisplatin with no adjuvant component to the control arm. So I think this is a really, really important study. Dr. Monty Pal: And share with us some of the results because this in my mind is definitely practice-changing. This is one of those studies that I think you walked into the office on Monday and you are like, "Okay, this is what I am doing now," right? Dr. Andrea Apolo: Yeah. So the study was positive. The primary endpoint was event-free survival, and it met the primary endpoint. The secondary endpoint of overall survival was also met. So really, really great results. Consistent with what we saw with EV-303, the median event-free survival was not reached for the EV plus pembro arm, and it was 48 months for the patients receiving gem-cis. And then looking at the 24-month estimated event-free survival, it was 79% for the EV plus pembro and 66% for the chemo, the gem-cis arm. And that was a hazard ratio of 0.5. So that is really exciting. That is the event-free survival. And then the overall survival, the medians were not reached for either arm, but when you look at the 24-month estimated overall survival, it was 87% for the EV plus pembro versus 81% for the gem-cis, and that was a hazard ratio of 0.65. So very positive study.  And then another question that we had was the pathologic CR rate. Very consistent with what we saw with the EV-303, the pathologic response rate was about 56% for the patients that received EV plus pembro and about 32%, 33% for the patients that received gem-cis. So very consistent with the findings that we have been kind of seeing in phase 2 studies, and this is a pT0N0, so that is important. Dr. Monty Pal: So Andrea, you know, I think that the big question in folks' minds is at this point, we see the data from NIAGARA, cis-gem-durva, we have now seen this data. Put it into context for us. Is there a patient in this day and age who maybe shouldn't get IO altogether, who should maybe get the NIAGARA regimen as opposed to EV-pembro in this context? What are your thoughts there? Dr. Andrea Apolo: Now, that is a great question. I would say with this data, it is very enticing to give EV pembro to our patients in the perioperative setting, and for that to be the new standard of care for all patients, regardless of cisplatin eligibility. So similar to what we saw with EV-302 really changing the standard of care in the frontline setting, I think these two studies, the EV-303 and the EV-304, change the standard of care for patients with muscle-invasive bladder cancer in the perioperative setting, and this should be the new standard of care if the patients don't have a restriction to receiving an immunotherapy. Dr. Monty Pal: I totally agree with that assessment. It is great to hear it from the expert's mouth as well. Thanks a lot for that, Andrea.  The next abstract I wanted to tackle is one that is, I would say, near and dear to my heart because I know these folks really well. It is led by the SWOG group, and this is SWOG S1602. The number there for the audience gives you a sense of how long the study has been running for. The 16 prefix means it is something that we kicked off back in 2016. So this study is really 10 years in the making, right? So Rob Svatek presented this data. It is interesting, right, because it addresses this issue of the BCG (Bacille Calmette-Guérin) shortage, right, where we have needed to sort of rely potentially on other alternative sources or regimens and so forth. Tell us about this trial, Andrea. Dr. Andrea Apolo: This is one of my favorite studies. We talked about putting it in the main oral abstracts, but we put it in one of the educational sessions that talked about non-muscle-invasive bladder cancer because we thought that would be the best audience for it. But it doesn't take away from how important this abstract is, and the tremendous effort that went into the study. Almost a thousand patients enrolled. I think 984 were eligible to enroll in this study. So it is a very high enrolling, randomized, cooperative group study in high-grade non-muscle-invasive bladder cancer. And really the study was designed to address two questions. One is the BCG shortage and can we use a different strain, Tokyo versus TICE? And whether there is a priming effect if you gave intradermal BCG to patients with non-muscle-invasive bladder cancer, can that enhance the effect if you gave it a little bit earlier? I think the study is really important, and it met its primary endpoint, which was it is not inferior to TICE. The findings were really terrific in terms of the outcomes. Numerically. When you look at the endpoint, it looked like the Tokyo strain was as good, if not maybe a little bit better, but not statistically significant than the TICE. And then they broke it down by carcinoma in situ, they broke it down by papillary tumors, and the Tokyo strain was non-inferior in both of those instances. But interestingly, the intradermal BCG did not change outcomes. There was really no priming effect, which was really backed up by pre-clinical data that there would be, but there wasn't a priming effect when the intradermal BCG was given in the Tokyo strain. So that was a really, really interesting finding. But a great study, really important outcomes in the field for non-muscle-invasive bladder cancer. Dr. Monty Pal: Totally. And it just seems like we can't get away from BCG, right? You know, as hard as we try, I mean, I appreciate the studies that sort of build on it that are emerging right now, but it seems like BCG at least for the foreseeable future is kind of here to stay, right? Dr. Andrea Apolo: It works. It is one of the most effective treatments we have for non-muscle-invasive bladder cancer. So, you know, I think it is here to stay and, you know, we need to find alternatives in terms of strains so we don't deal with this shortage that we have been dealing with for so many years now. Dr. Monty Pal: Yeah, indeed. Moving on to some of the other highlighted studies from the meeting, you had mentioned the EV-303 data, so we probably don't need to rehash that study design in much detail. But there was also a rapid oral abstract presented by Dr. Ullén that I think is of interest here, right, that really hones in on pathologic outcomes and DFS from that trial. Do you mind just outlining that for our listenership? Dr. Andrea Apolo: This is the KEYNOTE-905, also known as the EV-303 study. This is a follow-up to the EV-303 data looking at the pathologic response rates, looking at the downstaging effect, looking at the surgical margins after treatment with the neoadjuvant EV plus pembro in the 303. Now, remember in the 303, patients got three cycles of neoadjuvant EV plus pembro and then six cycles in the adjuvant setting. A little bit different than the 304, where they got four cycles, which is really kind of the standard in the neoadjuvant setting, and then five cycles in the adjuvant setting. So still a total of nine cycles. But in the 303, the treatment arm had no systemic therapy, so it was just radical cystectomy. And they looked at the negative margins that you get with the EV plus pembro treatment, which was 92.6% versus 79% with patients receiving just the surgery alone. And then the pathologic CR rate, there was more follow-up on that, it was 57% for the patients receiving EV plus pembro, and as we would expect, about 9% for the patients that just went on to surgery alone because you can achieve a pathologic response rate with TURBT alone. Then they looked at the pathologic downstaging, so anything less than a pT2, and that was 66% in the patients that received the EV plus pembro. So very interesting findings, and it is also really just nice to have now the EV-304 data, like I was saying, there were two pieces of it, the cisplatin-eligible and the cisplatin-ineligible, and just to have those contemporary controls are really important. How did the cisplatin-ineligible do versus the cisplatin-eligible patient in terms of the event-free survival and in terms of the overall survival? So I feel like now we have all of this data that we can kind of put together in the perioperative setting and we can really inform our patients a little bit more about their outcomes depending on whether they are cisplatin-eligible or not, which you know cisplatin-ineligible patients often just, they are sicker, they may have obstruction, their tumors may be larger, they just tend to be a more delicate population than the cisplatin-eligible patients. So not surprisingly, you know, we see that in the EV-303 the disease-free survival for the patients is pretty poor. So the disease-free survival that was reported for this follow-up of the specific abstract was 23.6 months for the patients that just got surgery, and it was not reached for the patients that had the EV plus pembro, and that was a hazard ratio of 0.37. Dr. Monty Pal: Excellent, excellent distillation. So Andrea, in the interest of time, I mean, we could probably talk about bladder cancer forever, but I am going to move us on to the subject of kidney cancer. We have two late-breaking abstracts, LITESPARK-011, which looked at lenvatinib and belzutifan versus cabozantinib in the advanced setting, and then we have an adjuvant study, LITESPARK-022, that looked at pembrolizumab with or without belzutifan in the adjuvant setting. Both studies positive. One for progression-free survival, the other for disease-free survival. Both I think making a big dent in how we treat kidney cancer. Can you tell us a little bit about that? Dr. Andrea Apolo: Yeah, we have been waiting for these trials for a long time. So one of the things that we have been talking about at GU ASCO is to have plenary sessions. And if we would have had a plenary session, these two abstracts would have been part of it because they are important data, really big studies where we are trying to improve the outcomes of our patients with kidney cancer. So the first one, the LITESPARK-011, like you said, this is for advanced renal cell carcinoma, clear cell renal cell carcinoma, where we really don't have a standard of care after IO therapy, right? So we give IO-IO, we give VEGF-IO, but we don't really have a good standard of care. We usually give monotherapy TKIs. So the combination of belzutifan and lenvatinib versus what a standard of care is, cabozantinib, is really an important question to ask. And you know, this is a pretty large study, about 750 patients were randomized. And belzutifan plus lenvatinib demonstrated an improvement in progression-free survival and overall survival versus cabozantinib, but not overall survival, at least not yet, is what the authors are saying. So for the progression-free survival, the hazard ratio was 0.7 and it was 14.8 months for the combination, belzutifan plus lenvatinib arm versus cabozantinib, which was 10.7 months. So I think that is significant. And for the overall survival, it did favor the combination again with a hazard ratio of 0.85. The median was 35 months versus 28 months for the monotherapy cabozantinib, but it did not reach statistical significance. And the authors said that this will be further tested at a final analysis, these were the interim results.  And for the overall survival, the overall survival was 53% for the combination versus 40%. This is significant. And the CR rates were lowish for both of them, it was like 5% for the combo and 1% for cabo monotherapy. So I think that the findings are important because we don't have a standard of care. And although there is no survival benefit, there was a trend. So I think this could be considered in patients that are fit, a treatment option for these patients in the later line settings. Dr. Monty Pal: Great points. I mean lots of great discussion around toxicity as well as efficacy. I mean certainly this is a regimen that may not be suitable for every patient in my portfolio, but certainly one to consider.  Now Andrea, let's shift focus to LITESPARK-022, the adjuvant trial that I mentioned previously. So this is again looking at pembrolizumab with or without belzutifan, met the primary endpoint of disease-free survival. What are your impressions there of the data? Dr. Andrea Apolo: Yeah, the data looks great. And this was a really large study, 1,800 patients were randomized, and the study met the primary endpoint of disease-free survival, benefiting the combination of pembro plus belzutifan. And that is really terrific. The medians were not reached for either arm. And in terms of the overall survival results, also the medians were not reached, but the hazard ratio was 0.78 and did not reach a statistical significance. So there was again a statistically significant improvement in disease-free survival for the combination of pembrolizumab plus belzutifan, but not an overall survival benefit.  So I guess, Monty, you know, we can kind of talk about what that means. There was a lot of discussion about belzutifan and some of the side effects, specifically anemia and managing anemia in this setting and requirements for transfusions. Generally, the authors said it was well tolerated, but we know that combination studies do have more toxicity. So it may be a select group of patients again, similar to the advanced setting, where we opt for a combination, possibly until we see more follow-up data in terms of the overall survival. Dr. Monty Pal: I have to agree with you. You know, in my group, we have been talking about a lot of pembrolizumab-based studies that are running right now, some through the NCI, some, you know, our own sort of homegrown investigator-sponsored trials, and you know, I think for the foreseeable future we are comfortable just maintaining pembrolizumab. Things might change if, for instance, we ultimately see a survival advantage emerge, but I just have my own personal doubts around that, that will be interesting.  Okay, so now we are going to move to the last disease category that we are going to cover, which is prostate cancer. So there, we have the long-awaited results from the PEACE-3 study. These are the final OS results from this trial looking at enzalutamide with or without radium-223 in metastatic castration-resistant prostate cancer. So Andrea, would love to get your perspectives on this. Dr. Andrea Apolo: Yeah, so this study had been presented before and we had seen positive results for the combination of enzalutamide and radium with some interim overall survival results also showing a benefit. But like you said, these are the final results with a median follow-up of 58 months. So it was really nice to see the final results. And with the combination of enzalutamide and six cycles of radium, it did show an improvement in overall survival with a hazard ratio of 0.76. The median overall survival increased from 32.6 months to 38.2 months with the combination. So that is really great. There was some crossing over of the overall survival curves around 18 months was still seen. And again, there was also an improvement in the rPFS with a hazard ratio of 0.71, and the median rPFS improved from 16.4 to 19 months with the combination. So, you know, we have been awaiting the final results, but we kind of knew a lot about the benefits of the combination. And it is something that is kind of slowly trickling into the community in terms of adapting it and using it. There is more buzz now about it and I think these overall survival results will hopefully shift the community into incorporating the combination in these patients. Dr. Monty Pal: Brilliant. So well said. I mean, Andrea, congratulations on a terrific meeting. You have really done it again. Incredible, incredible output from this year's ASCO GU. I just want to thank you for joining us on the program today. Dr. Andrea Apolo: Oh, thank you so much for having me, Monty. It was really a joy to work with the ASCO team and with all the investigators and the Education Committee and the Scientific Committee. Everyone was really outstanding. So to me it was an honor to be part of this meeting, and I am so happy that it was so successful and really presented some amazing data that I think will be practice-changing to our patients. Dr. Monty Pal: Oh, thanks a ton. And also a huge thanks to our listeners. If you enjoyed the content of today's podcast, please don't forget to like and subscribe to our channel wherever you listen to podcasts. Thanks so much. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Follow today's speakers:     Dr. Monty Pal   @montypal  Dr. Andrea Apolo @apolo_andrea  Follow ASCO on social media:          ASCO on X    ASCO on Bluesky         ASCO on Facebook          ASCO on LinkedIn          Disclosures:       Dr. Monty Pal:      Speakers' Bureau: MJH Life Sciences, IntrisiQ, Peerview     Research Funding (Inst.): Exelixis, Merck, Osel, Genentech, Crispr Therapeutics, Adicet Bio, ArsenalBio, Xencor, Miyarsian Pharmaceutical     Travel, Accommodations, Expenses: Crispr Therapeutics, Ipsen, Exelixis     Dr. Andrea Apolo: No disclosures to report.

How solid is your CMC foundation—and what happens if it cracks under pressure?David Brühlmann welcomes Henri Kornmann, former Head of Biologics Innovation Centre at Ferring Pharmaceuticals. From junior CMC scientist at Merck to leading Ferring Pharmaceuticals' first gene therapy approval for bladder cancer, Henri has moved repeatedly between CMC development, GMP manufacturing, and due diligence across some of the industry's most complex programs.His “house building” approach demystifies CMC's complexity, showing why early diligence paired with regulatory fluency and scientific insight pays dividends for years.Tune in to hear Henri's practical wisdom distilled through real-world analogies:Building a strong CMC foundation in early phases and why later fixes can be costly or impossible (02:45)Scaling up: supplying Phase 3 with the final commercial process, including robustness and supply chain strategies such as dual sourcing critical raw materials (03:23)Process validation explained: FDA's three stages, from control strategy justification to continued verification (05:15)Process Performance Qualification (PPQ): what it is, how many batches are needed, and optimizing timing (07:43)Handling lifecycle changes: maintaining process control, adapting to deviations, and improving systems after regulatory approval (09:34)Managing teams, stakeholders, and cross-functional collaboration in CMC programs (11:49)Importance of good project management, access to scientific expertise, and interpreting guidelines for your specific program (12:27)The “half scientist, half lawyer” analogy for mastering both technical and regulatory aspects (15:08)Smart insight:Never underestimate CMC. If you do, you will pay for it later.If this topic resonates with you, here are a few related episodes where we dive deeper into building strong CMC foundations and avoiding costly development mistakes:Episodes 199 - 200: Mastering Quality by Design: From Product Failures to Commercial Success in Biologics CMC DevelopmentEpisodes 189 - 190: Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later)Episodes 23 - 24: Strategies for Success: Master CMC Development with Gene LeeEpisodes 57 - 58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls with Matthias MüllnerConnect with Henri Kornmann:LinkedIn: www.linkedin.com/in/henri-kornmann-9b6869Next step:Need fast CMC guidance? → Get rapid CMC decision support hereSupport the show

Host: Sabiha Gati Guest: Thomas F. Luescher Want to watch that extended interview on The future of guidelines in an era of Big Data and AI, go to: https://esc365.escardio.org/event/2556?resource=interview Want to watch the full episode? Go to: https://esc365.escardio.org/event/2556 Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode.  The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Sabiha Gati, Nicolle Kraenkel and Thomas F. Luescher have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada.  Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

This episode covers: Cardiology this Week: A concise summary of recent studies The future of guidelines in an era of big data and AI Exercise in hypertrophic cardiomyopathy Snapshots Host: Sabiha Gati Guests: Kostas Koskinas, Thomas F. Luescher, Michael Papadakis, Stephan Achenbach Want to watch that episode? Go to: https://esc365.escardio.org/event/2556 Want to watch the extended interview on The future of guidelines in an era of Big Data and AI, go to: https://esc365.escardio.org/event/2556?resource=interview Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode.  The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Sabiha Gati, Nicolle Kraenkel and Thomas F. Luescher have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada.  Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of compelling stories that highlight the intricate interplay of scientific innovation, regulatory dynamics, and strategic maneuvers shaping the industry.Starting with Moderna, the company has reached a pivotal resolution in a long-standing patent dispute involving its mRNA-based COVID-19 vaccine, Spikevax. This settlement involves a hefty $950 million payout to Genevant Sciences and Arbutus Biopharma, resolving claims of patent infringements. This agreement underscores the complex nature of intellectual property in the rapidly evolving mRNA landscape. Securing patent rights is crucial as new vaccines and therapies are developed, and this resolution not only clears a legal hurdle for Moderna but also exemplifies the industry trend towards resolving such disputes to foster continuous innovation.Sanofi has embarked on a significant strategic move by entering a $1.53 billion global licensing deal with Sino Biopharmaceutical. This agreement secures rights to a first-in-class JAK/ROCK inhibitor, which shows promise in treating hematological and immunological conditions. Such collaborations reflect the increasing focus on innovative therapies that target complex biological pathways, highlighting how companies are seeking unique assets to bolster their competitive edge.Regulatory scrutiny continues to be a formidable theme in the industry. The FDA has intensified its oversight on compounded GLP-1 drugs, issuing 30 warning letters to telehealth companies marketing unauthorized versions. This action highlights the agency's commitment to ensuring drug safety and efficacy while emphasizing the challenges companies face in navigating regulatory landscapes for compounded medications. Additionally, Novo Nordisk has been cautioned by the FDA regarding advertising practices for GLP-1 receptor agonists, illustrating the ongoing regulatory focus on pharmaceutical marketing strategies and compliance standards.Meanwhile, Bayer is experiencing a period of resilience in its pharmaceutical division, driven largely by its cancer drug Nubeqa and cardiovascular agent Kerendia. Despite these successes, Bayer faces challenges as revenues from older drugs like Xarelto and Eylea decline. This scenario reflects a broader industry challenge where companies must innovate while managing mature product lines facing generic competition.Teva Pharmaceuticals is making strategic strides by securing a $400 million deal with Blackstone to develop an anti-TL1A antibody for inflammatory bowel disease (IBD), in partnership with Sanofi. This investment highlights continued interest in autoimmune and inflammatory conditions as lucrative targets for novel therapies. Financial partnerships like Teva's substantial agreement with Blackstone illustrate how such collaborations can support sustained R&D efforts in chronic disease management.Technological integration into healthcare is expanding rapidly, with Nvidia collaborating with Droplet Biosciences to explore AI applications in medtech and cancer research. These partnerships illustrate an industry shift towards leveraging artificial intelligence to enhance diagnostic capabilities and accelerate research efforts. Moreover, collaborations leveraging AI/ML technologies across drug discovery pipelines are gaining traction; Earendil Labs partnering with WuXi XDC exemplifies this trend alongside Merck & Co.'s multi-year AI oncology data deal with Tempus—enhancing precision medicine capabilities while expediting therapeutic discoveries.In terms of funding new therapeutic areas, ARPA-H has announced a $158 million initiative aimed at developing medicines targeting the lymphatic system. This marks an exploration into less charted territories within physiological research that could yield transforSupport the show

Marc Soldevila de Divacons Alphavalue analiza los títulos de compañías como Merck, Bayer, DHL...

Heute ist Donnerstag, der 5. März und Peter Bloed und Sina Osterholt sprechen über den KI-Höhenflug von Broadcom, enttäuschende Zahlen von der Deutschen Post und Merck und warum der Spritpreis an der Tankstelle eigentlich so viel schneller steigt als der Öl-Preis ------ Ihr habt Fragen, schreibt uns an: missionmoney@focus-money.de Alle wichtigen Links: https://wonderl.ink/@mission_money

APAC stocks extended on losses with markets roiled by the widening conflict in the Middle East; KOSPI saw a double-digit percentage drop and had triggered a circuit breaker with declines led by shipbuilders and shipping firms.Iran hit more than 10 tankers that ignored warnings and warns ships against transiting the Strait of Hormuz, according to FARS.US President Trump said, "If necessary, the United States Navy will begin escorting tankers through the Strait of Hormuz, as soon as possible".US President Trump announced with immediate effect that the US is to provide political risk insurance and guarantees (at a very reasonable price) for the financial security of all maritime trade, especially energy, travelling through the Gulf.European equity futures indicate a slightly lower cash market open with Euro Stoxx 50 futures down 0.4% after the cash market closed with losses of 3.6% on Tuesday.Looking ahead, highlights include Swiss CPI (Feb), Global Final Composite/Services PMIs (Feb), EZ Unemployment (Jan), PPI (Jan), US ISM Services PMI (Feb), NBP Policy Announcement. Speakers include ECB's Cipollone, de Guindos & BoC's Macklem. Supply from Germany, Earnings from Broadcom, Merck & Deutsche Post.Read the full report covering Equities, Forex, Fixed Income, Commodites and more on Newsquawk

Stephen Framil, Corporate Global Head of Accessibility at Merck, shares how he embedded accessibility into enterprise digital governance across more than 125 countries. From authoring a global accessibility policy to integrating controls into procurement, SDLC, and clinical trial protocols, Stephen explains how accessibility must be “baked in” rather than bolted on. Drawing from his background as a conductor, musician, and cancer survivor, he describes accessibility leadership as orchestration—guiding experts toward inclusive outcomes while normalizing accessibility across systems and culture.Mentioned in this episode:Info about Accessibility at Blink

The FDA is dominating the headlines once again thisweek.  Days after FDA Commissioner Marty Makary appeared to question uniQure's gene therapy candidate for Huntington's disease, the company revealed that the agency will require it to conduct a randomized, double-blind, sham surgery–controlled Phase 3 study. The FDA also published anothercomplete response letter (CRL), this one for REGENXBIO's gene therapy for Hunter syndrome. The rejection, sustained by the biotech early last month, was driven by issues with the study's population, controls and use of surrogate markers to measure efficacy, according to the document.  Meanwhile, regulatory experts have expressed concernsthat the FDA's circle of trust is shrinking, making many decisions feel like “fiat”—both in terms of individual drug applications and policy. The FDA has reportedly initiated a probe into complaints that a toxic workplace is fostered by CBER director Vinay Prasad, who is at the heart of many of these decisions. Finally, the biopharma industry continues to react to the agency's pivot from a requirement of two pivotal trials to one for approval, asking why now, what are the risks and what exactly the FDA expects from this one trial.   Still on the gene therapy front, Sarepta Therapeutics CEO Doug Ingram stepped down last week to spend more time with family as the company's muscular dystrophy mission hits home. Also during the company's fourth quarter earnings call, Sarepta projected that sales of its embattled Duchenne muscular dystrophy gene therapy Elevidys will be flat or down as far as 15% in 2026.  On the obesity front, Eli Lilly topped Novo Nordisk again in a weight loss trial, this time in a Lilly-sponsored study of patients with type 2 diabetes. But don't count Novo out yet. The company is actively seeking out new obesity assets, according to business development executive Tamara Darsow. Just last week, Novo linked with Boston'sVivtex to advance novel weight loss pills.Finally, check out BioPham Executive this week for a rundown of 2025's top-selling assets—spoiler: Merck's Keytruda held onto its crown as number one—and a story on former2seventy exec Chip Baird's new role as CEO of recently launched Poplar Therapeutics, which secured a $45 million series A extension this week.

Seventy percent of FDA Complete Response Letters have a CMC root cause. Most of those failures trace back to decisions made years earlier. Decisions that felt minor at the time and proved impossible to fix later.Henri Kornmann has spent two decades making those decisions the right way. From junior CMC scientist at Merck to leading Ferring Pharmaceuticals' first gene therapy approval for bladder cancer, Henri has crossed between CMC development, GMP manufacturing, and due diligence across some of the industry's most complex programs. His conclusion: a CMC program is like building a house. Get the foundation wrong and no amount of late-stage effort will save you.In Part 1, Henri reveals the decisions that cannot be undone and how to get them right from the start.What you will learn:Evolution of cell bank technology and regulatory expectations (00:33)The impact of weak CMC foundations on late-stage failure (00:51)Lessons learned from Ferring's gene therapy approval and CMC gap analysis (06:51)FDA statistics on CMC issues in INDs and response letters (08:07)Critical early decisions: cell bank clonality and proper storage practices (10:22)The importance of comprehensive raw material documentation (12:29)Early analytical characterization and discovering molecular “funkiness” before phase trials (13:41)Supply strategy for phase 2—why stability and batch knowledge matter (14:49)Introduction to critical quality attributes (CQA), process parameters, and quality-by-design principles (15:52)Common pitfalls in CQA identification and continued process verification (17:01)Smart insight:The therapies that reach patients aren't built on heroic late-stage rescues. They're built on disciplined early decisions: the right cell bank, the right analytics, the right documentation. Henri's message is unambiguous: there are CMC mistakes you can fix later, and there are CMC mistakes you cannot. Knowing the difference is the foundation of every successful biologics program.In Part 2, Henri walks through scale-up to commercial manufacturing, process validation stages 1 through 3, post-approval control strategy, and the project management and regulatory fluency that separate successful CMC leaders from the rest.If this topic resonates with you, here are a few related episodes where we dive deeper into building strong CMC foundations and avoiding costly development mistakes:Episodes 199 - 200: Mastering Quality by Design: From Product Failures to Commercial Success in Biologics CMC DevelopmentEpisodes 189 - 190: Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later)Episodes 23 - 24: Strategies for Success: Master CMC Development with Gene LeeEpisodes 57 - 58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls with Matthias MüllnerConnect with Henri Kornmann:LinkedIn: www.linkedin.com/in/henri-kornmann-9b6869Next step:Need fast CMC guidance? → Get rapid CMC decision support hereSupport the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of significant advancements and ongoing challenges that are reshaping the landscape of these dynamic industries.A key highlight in recent developments comes from Ascendis Pharma, which has secured FDA approval for Yuviwel, a treatment targeting achondroplasia, a genetic disorder leading to dwarfism. This approval underscores the potential of Ascendis' "transient conjugation" drug delivery platform, marking its third rare disease drug approval in just six years. The platform's ability to extend drug half-life and improve dosing frequency highlights its promise in addressing unmet medical needs in rare diseases, offering new hope for patients who previously had limited treatment options.In oncology, Merck's LITESPARC clinical trial program is showing promising results with Welireg (belzutifan) for clear cell renal cell carcinoma. The trials suggest that combination therapies involving Welireg could set a new standard of care. However, transitioning these regimens into universal standards remains challenging due to competitive dynamics and hurdles in clinical adoption.Shifting to cardiovascular health, United Therapeutics has made notable progress with its phase 3 trial success for a once-daily drug candidate for pulmonary arterial hypertension. The trial reported a 55% reduction in clinical worsening risk, positioning United Therapeutics to seek FDA approval and potentially challenge existing treatments from major players like Johnson & Johnson.Regulatory challenges are also evident. UniQure recently faced a setback when the FDA rejected its data package for AMT-130, a gene therapy for Huntington's disease. This rejection reflects the stringent regulatory environment surrounding gene therapies and emphasizes the need for robust data to meet approval criteria.On the technological front, Eli Lilly is making a strategic shift by collaborating with Nvidia to integrate advanced computing capabilities into drug development. By leveraging Nvidia's AI-driven supercomputing power, Lilly aims to accelerate drug discovery processes and enhance precision medicine approaches, potentially transforming traditional pharmaceutical lifecycles.Operational shifts are also occurring as Merck winds down Gardasil production at its North Carolina plant due to declining global demand. This decision reflects broader vaccination trends and may signal shifts in manufacturing strategies to align more closely with market demands.Leadership changes at Bavarian Nordic, following a failed private equity takeover bid, indicate potential strategic realignments within the company. The planned departure of CEO Paul Chaplin after 12 years could herald new directions and priorities.In logistics, Frontier Scientific Solutions is pioneering advancements in temperature-controlled supply chains—crucial for maintaining drug efficacy during distribution. Their innovative approaches are reshaping pharmaceutical logistics, ensuring reliable delivery systems worldwide.Meanwhile, Walgreens is venturing into digital health with a virtual weight management clinic offering access to GLP-1 medications. This move positions Walgreens within the competitive telehealth market as it responds to growing consumer demand for convenient healthcare solutions.These developments collectively reflect an industry in flux—balancing scientific innovation with regulatory rigor and strategic realignments. As companies navigate these challenges, the implications for patient care are profound, promising potential improvements in treatment efficacy and accessibility.Turning our attention to Roche, another successful Phase 3 trial for fenebrutinib—a BTK inhibitor targeting relapsing multiple sclerosis—has been reported. The study achieved its primary endpoint but raiseSupport the show

You know them by their trade names such as Ozempic, Wegovy, Mounjaro, and Zepbound. This class of medications is known as GLP-1 receptor agonists. And while they are best known for managing diabetes and promoting weight loss, researchers are finding that these drugs are also effective in a broad range of other health conditions. So, what about MS? My guest this week is Dr. Ellen Mowry, the principal investigator of a clinical trial to determine whether a GLP-1 drug can reduce brain inflammation and provide neuroprotection in people living with progressive MS. We're sharing details about the discovery of a new biomarker that not only confirms an MS diagnosis but also predicts the severity of an individual's disease course in the years ahead. We'll tell you about three studies focused on better managing some of the most common MS symptoms and funded by the International Progressive MS Alliance. And we'll explain how Merck and the Mayo Clinic are partnering to build a first-of-its-kind drug discovery platform using AI. We have a lot to talk about! Are you ready for RealTalk MS??! This Week: A GLP-1 for MS?  :22 I'm asking for your support:  1:31 Researchers discover biomarkers that can predict future disease course  2:13 The International Progressive MS Alliance invests $8.1 million in global studies that address the most common MS symptoms   5:44 Merck and the Mayo Clinic collaborate on AI-driven drug discovery platform  10:02 Dr. Ellen Mowry discusses the clinical trial to determine whether a GLP-1 drug can reduce inflammation in the central nervous system and offer neuroprotection to people with progressive MS  12:20 Share this episode  30:17 Next week  30:38 SHARE THIS EPISODE OF REALTALK MS Just copy this link & paste it into your text or email: https://realtalkms.com/444 ADD YOUR VOICE TO THE CONVERSATION I've always thought about the RealTalk MS podcast as a conversation. And this is your opportunity to join the conversation by sharing your feedback, questions, and suggestions for topics that we can discuss in future podcast episodes. Please shoot me an email or call the RealTalk MS Listener Hotline and share your thoughts! Email: jon@realtalkms.com Phone: (310) 526-2283 And don't forget to join us in the RealTalk MS Facebook group! LINKS If your podcast app doesn't allow you to click on these links, you'll find them in the show notes in the RealTalk MS app or at www.RealTalkMS.com Support Jon at WALK MS https://realtalkms.com/walkms STUDY: Large-Scale Proteomics Across Neurological Disorders Uncovers Biomarker Panel and Targets in Multiple Sclerosis https://pubmed.ncbi.nlm.nih.gov/41747728 International Progressive MS Alliance https://progressivemsalliance.org JOIN: The RealTalk MS Facebook Group https://facebook.com/groups/realtalkms REVIEW: Give RealTalk MS a rating and review http://www.realtalkms.com/review Follow RealTalk MS on Twitter, @RealTalkMS_jon, and subscribe to our newsletter at our website, RealTalkMS.com. RealTalk MS Episode 444 Guests: Dr. Ellen Mowry Privacy Policy

Are you holding yourself back from biotech roles because you don't check every box on the job description? You're not alone, and it's costing you opportunities.In this career chat, Carina sits down with Heer Shah, a Scientist in cell and gene therapy at Ensoma, a Boston-based biotech developing precision gene therapies using synthetic viral vectors and gene editing technologies. Heer has over seven years of biotech experience spanning vaccines, AAV, lentiviral vectors, VLPs, and LNPs, with roles at Merck, Intellia Therapeutics, Ring Therapeutics, and Sana Biotechnology. Heer holds a Master's in Biotechnology from Northeastern University, where the co-op program launched a career built on hands-on industry experience from day one. Today, Heer does vector engineering and gene editing optimization for programs targeting sickle cell disease and immuno-oncology.Heer shares how foundational lab skills and a big-picture mindset opened doors at every stage, and what it really takes to build a long-term biotech career across multiple modalities.Key takeaways from this episode:Why job descriptions are wish lists, not checklists, and why hiring managers value learning ability over a perfect resume matchHow to position diverse experience across biotech modalities as a competitive advantageThe difference between specialists and integrators, and why companies need bothWhat it's like surviving multiple rounds of biotech layoffs and how to build career resilienceHow the Northeastern co-op program helped Heer explore different company sizes and career paths before committingWhy behavioral interview questions often matter more than technical onesHow international scientists can navigate visa pathways, including the National Interest WaiverThe career advice Heer wishes someone gave earlier: tell your story soonerWhether you're early in your biotech journey or navigating a career transition, this conversation is packed with practical advice on building transferable skills, staying adaptable, and landing roles you're excited about.Want scripts, practice drills, and feedback from peers in biotech?Join our Biotech Career Coach Skool community: https://www.skool.com/biotech-career-coach/aboutConnect with Heer on LinkedInLearn more about the Collaboratory Career Hub community and access our free resources:Join our Skool CommunityTake the Free 7-day Interview Sprint ChallengeCheck out our sister podcast: Building BiotechsSend Carina a connection request on LinkedIn!Stay connected with us:

Guest: Martin Brenner, Ph.D., Chief Executive Officer and Chief Scientific Officer at iBioCompany: iBio, Inc. (NASDAQ:IBIO)Website: https://ibioinc.com/Martin's Bio:Dr. Brenner has a strong history of success heading drug discovery and development teams at several of the world's leading pharmaceutical companies, including AstraZeneca, Eli Lilly and Company, Pfizer Inc., and Merck Research Laboratories. Most recently, Dr. Brenner served as the CSO at Pfenex Inc., which, using its patented Pfēnex Expression Technology® platform, created an advanced pipeline of therapeutic equivalents, vaccines, biologics and biosimilars. Pfenex was acquired by Ligand Pharmaceuticals Incorporated for approximately $516 million in October 2020. Previously, Dr. Brenner served as the CSO at Recursion Pharmaceuticals, Inc., a company focused on accelerating drug discovery for rare diseases and diseases with high unmet medical need. Prior to his time at Recursion, he was Vice President and Head of Research & Early Development at Stoke Therapeutics, Inc., a biotechnology company using antisense oligonucleotides to increase gene expression for the treatment of rare diseases. Prior to Stoke, he was Executive Director at Merck, where he built a biotech unit from scratch, focusing his team's research on diabetes and nonalcoholic steatohepatitis (NASH). Earlier in his career, Dr. Brenner was the Senior Director and Head of cardiovascular, renal, and metabolism (CVRM) biosciences at AstraZeneca. In addition, Dr. Brenner was an Associate Research Fellow at Pfizer where he led the islet biology and in vivo pharmacology in the CVMED Target Exploration Unit before assuming the role of Head of the Insulin Resistance Group.Company Description: iBio is a cutting-edge biotech company leveraging AI and advanced computational biology to develop next-generation biopharmaceuticals for cardiometabolic diseases, obesity, cancer and other hard-to-treat diseases. By combining proprietary 3D modeling with innovative drug discovery platforms, iBio is creating a pipeline of breakthrough antibody treatments to address significant unmet medical needs. iBio's mission is to transform drug discovery, accelerate development timelines, and unlock new possibilities in precision medicine.

Gregory Zuckerman details Gail Smith's insect-based vaccine technology at Novavax and discusses how major pharmaceutical giants like Merck initially hesitated to join the pandemic race. 4

The I Love CVille Show headlines: Henley Middle School ICE Truancy Student Protest Today Are We Accepting 12 Year Olds Skipping School? Elementary School Students Next Age Group To Protest? AlbCo Supe Pruitt Says Funding Not There For 4th HS VA Judge Blocks Democrats' Gerrymandering Efforts UVA BOV Names Dominion Energy Boss As Rector Eli Lilly, AstraZeneca, Merck: $12.5B + 1,750 New Jobs In Area The Most Important 3 Minutes Of News Today (2/20/26) Read Viewer & Listener Comments Live On-Air The I Love CVille Show airs live Monday – Friday from 12:30 pm – 1:30 pm on The I Love CVille Network. Watch and listen to The I Love CVille Show on Facebook, Instagram, Twitter, LinkedIn, iTunes, Apple Podcast, YouTube, Spotify, Fountain, Amazon Music, Audible, Rumble and iLoveCVille.com.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of transformative events reshaping the industry landscape, from scientific breakthroughs to regulatory shifts and strategic corporate maneuvers.Let's start with Insmed's Brinsupri, a newly approved respiratory therapy that has captured attention with its projected $1 billion in sales by 2026. This ambitious forecast is grounded in Brinsupri's robust clinical efficacy and the increasing demand for innovative respiratory treatments. This development reflects a broader industry trend where targeted therapies are not only improving patient outcomes but also driving significant revenue growth. As respiratory conditions continue to be a major health challenge globally, the success of therapies like Brinsupri underscores the potential for innovation to meet these critical needs.In parallel, Merck is working strategically with its RSV antibody, Enflonsia, seeking a second-season approval to bolster its competitive stance against Sanofi and AstraZeneca's Beyfortus. The race in infant RSV prevention is intense as companies vie to establish dominance in this crucial segment of infectious disease management. Merck's efforts highlight the broader push within the industry to develop preventive measures that could significantly alter public health landscapes by reducing the incidence of severe respiratory illnesses in vulnerable populations.Meanwhile, regulatory scrutiny remains a constant for pharmaceutical companies. The FDA's recent review of Johnson & Johnson's advertising for Tremfya, targeting ulcerative colitis, emphasizes the agency's commitment to ensuring that efficacy claims are both truthful and transparent. This serves as a reminder of the importance of maintaining regulatory compliance and ethical advertising practices within the industry—a critical aspect as companies navigate complex marketing landscapes while ensuring patient trust.Shifts in leadership within key health organizations are also noteworthy. Jay Bhattacharya stepping into the role of acting CDC chief after Jim O'Neill's departure could signal changes in public health policy and research priorities. Such transitions can have profound effects on how emerging health challenges are addressed, potentially influencing everything from vaccine distribution strategies to research funding allocations.As we turn to policy discussions, President Donald Trump's most favored nation drug pricing proposal continues to stir debate. This initiative aims to lower drug prices by benchmarking them against international rates, but it faces resistance from free-market advocates who argue it could stifle pharmaceutical innovation. The ongoing discussion around drug pricing reform is pivotal, as it impacts both patient access to medications and the incentives for companies to invest in new drug development.Strategic realignments in the contract development and manufacturing organization (CDMO) sector are also making headlines. Recipharm's sale of its Israeli API plant to Scinai Immunotherapeutics, alongside a new CDMO partnership, illustrates how companies are optimizing resources to focus on core competencies and expand service offerings. This strategic shift highlights the dynamic nature of CDMOs as they adapt to changing market demands and technological advancements.In Alzheimer's research, there's promising news with a study suggesting that a blood test could predict when symptoms will appear, representing a significant leap forward in early diagnosis and intervention strategies. These advancements offer hope for altering the treatment landscape of neurodegenerative diseases through timely therapeutic interventions that could improve quality of life for patients. However, challenges remain as seen with Johnson & Johnson pausing enrollment in itsSupport the show

Dr. Monty Pal and Dr. Ari Rosenberg discuss the evolution of treatment strategies in head and neck cancers, including the challenges of treating both HPV-positive and HPV-negative disease and the emergence of blood-based biomarkers to advance personalized therapy across different subtypes. TRANSCRIPT Dr. Monty Pal: Hello and welcome to the ASCO Daily News Podcast. I'm your host, Dr. Monty Pal. I'm a medical oncologist, professor, and vice chair of academic affairs at the City of Hope Comprehensive Cancer Center in Los Angeles. Today, we're going to explore the evolving landscape of treatment strategies in head and neck cancer management, including locoregionally advanced head and neck squamous cell carcinoma, which happens to be on the rise in United States, in part due to spike in HPV-mediated oropharyngeal cancers. We're also going to discuss the emerging strategies of using blood-based biomarkers to really advance personalized therapy. Joining me for this discussion is Dr. Ari Rosenberg. He's a medical oncologist focused on head and neck cancer, and he's an associate professor – congratulations on the recent promotion – at the University of Chicago. The University of Chicago has really produced luminaries in this field, Dr. Rosenberg included. I've had the pleasure of getting to know Dr. Ezra Cohen over the years, who really had his grounding there, and of course Everett Vokes, former ASCO President. I'm really looking forward to this conversation, Ari. Thanks so much for joining us. Dr. Ari Rosenberg: Thanks, Monty. Thanks for the invitation. Dr. Monty Pal: You got it. And just a quick note for our listeners, our full disclosures are going to be in the transcript at the end of this episode. So let's start with the basics, if you don't mind. So, head and neck cancers are very diverse and they're challenging, right? In the sense that they're near vital organs, the treatments, you know, as we all saw during fellowship, if not now in clinical practice. They can really have such a major impact on vital organ function, speech, swallowing, et cetera. Can you just comment on head and neck cancers that are on the rise in the U.S.? I alluded to this briefly. Particularly, we've heard this in the context of colorectal cancer and so forth. Are you actually seeing younger adults being affected by this? Dr. Ari Rosenberg: Yeah, thanks for that. The vast majority of head and neck cancers are head and neck squamous cell carcinomas, as I'm sure many of the listeners recall as well from fellowship or their current training. And as you alluded to, the organ function, long-term and functional quality of life outcomes are quite important, particularly in the context that these develop in high value real estate, parts of our head and neck area that we use for speaking, swallowing, all sorts of other essential functions as well. As you also alluded to, we think of this in two different particular subtypes of head and neck cancer. The historical head and neck cancer from 50, 60 years ago was almost exclusively related to carcinogen exposure, tobacco, alcohol use, and that subtype of carcinogen-induced head and neck cancer has been slowly declining. However, over the last now several decades, we've been seeing an increase in primary oropharyngeal squamous cell carcinoma, mostly tonsil, base of tongue. These are attributable to HPV, human papillomavirus exposure. And that's now the majority of the head and neck cancers that we tend to see in our clinic. As you also alluded to, these have very different prognoses as well. HPV-related head and neck cancer has a much more favorable prognosis where much of the interest has been in can we de-intensify to optimize long-term function? But then the non-HPV-related head and neck cancer, or what we call HPV-negative head and neck cancer, continue to be very, very challenging. We only managed to cure about half of these folks, with many of these patients developing the current disease. These patients, in addition to being difficult to treat, also have major impacts both in terms of the treatments they undergo as well as their disease that can impact their function and quality of life. And you hinted at this a little bit, but we have been seeing an increase in younger patients with HPV-negative head and neck cancer as well, which is quite concerning. Younger patients, oftentimes never smokers, never drinkers, who are developing non-HPV-negative head and neck cancer. And that's been a little bit of a more recent trend that we've been seeing as well. So, definitely a lot of work to be done to optimize and improve outcomes across all of these different head and neck cancer subtypes. Dr. Monty Pal: I mean, I'm just curious, you know, in the context of colorectal cancer, one of the things that we talk about is the potential role of the microbiome driving some of these young-onset cancers with, you know, perhaps there being an impact on, for instance, inflammation and the gut and what have you. Tell me about head and neck cancer. Is this anything known as to why younger patients might be getting diagnosed with non-HPV type cancers? It's odd to me. Dr. Ari Rosenberg: Yeah, it's a great question. A lot of people are working on it. I think we folks have hypotheses, but it hasn't totally panned out exactly what's going on there. It does have a little bit more of a tendency towards women, whereas historically head and neck cancer is much more common in men than it is in women. But lots of people working on that, whether it's related to chronic inflammation, whether it's related to the microbiome. Whether it's related to dental exposure, dental work. So, a lot of folks trying to parse that out because I agree with you, it needs to be identified alongside improving treatment paradigms for these patients, the young ones and the older patients as well. Dr. Monty Pal: Interesting, interesting. You know, one of the phenomena that was sort of coming around when I was in training 25 years ago was this role of sort of induction therapy for head and neck cancers. And of course, it's really come full circle now to include checkpoint inhibitors and so forth. Tell me a little bit about this and how you apply it, maybe in an HPV-mediated context, maybe in a non-HPV context. Dr. Ari Rosenberg: Yeah, absolutely. Induction chemotherapy, as you alluded to, or neoadjuvant chemotherapy, depending on what the locoregional treatment approach is. Similar to other cancer types where systemic control early on has many potential advantages in this setting. Now, in head and neck cancer, even though induction chemotherapy is quite active in head and neck cancer, both HPV-positive and HPV-negative with pretty good response rates. A survival advantage for all comers with local regionally advanced disease remains unproven. There's been two randomized trials, both underpowered, but essentially did not show a survival advantage, showing that induction chemotherapy for all patients with locoregionally advanced and neck cancer can't be justified for a survival advantage. That being said though, there remains a number of potential advantages of giving induction or neoadjuvant chemotherapy, of course, improving systemic control and debulking the disease early on has potential advantages, and predicting the responsiveness to subsequent radiation treatment. We know for some time in head and neck cancer that the percentage of shrinkage or the response to induction chemotherapy actually predicts outcome related to radiation as a dynamic biomarker where response can be used to select patients, for example, for de-escalated radiation has been an area of active investigation, active research. And it also remains a key opportunity to evaluate predictive biomarkers and understanding pre and post treatment to better understand the biology. I'll just add to your question that recently over this past year, we also saw phase 3 data for neoadjuvant immunotherapy for a subset of head and neck cancer that is surgically resectable. And so that's reintroducing the potential benefit in the immunotherapy era of incorporating immunotherapy in the neoadjuvant or the induction setting as part of the evolving treatment paradigm for these diseases. Dr. Monty Pal: That's really interesting. And you kind of alluded to already several topics that I plan to hit on, you know, for instance, the role of immune checkpoint inhibitors, induction, chemotherapy, and so forth. And you started to touch on biomarkers. And of course, I think that's something near and dear to many of us in academic oncology. One thing that we've started talking a lot about in the context of colorectal cancer is circulating tumor DNA. How do you think this might fit in the context of head and neck cancer? Can you give us a flavor for that? Dr. Ari Rosenberg: Yeah, absolutely. In head and neck cancer, the current landscape is most developed for circulating tumor DNA for HPV-related head and neck cancer. The advantage of HPV-related head neck cancer is that you have a distinctive HPV DNA that does tend to spill out into the peripheral blood and can be detected using various different blood-based assays. And because of that advantage as a tissue agnostic approach, it turns out that a number of HPV DNA plasma assays are actually quite sensitive and quite specific. And a number of them have indeed been commercialized. Of course, not only for detecting a baseline, but also grading responsiveness during treatment and probably most importantly in the post-treatment surveillance setting, the detection of HPV DNA in the plasma remains a very important and substantial predictor of developing recurrent disease. There's been a number of trials that have been emerging looking at ctDNA and HPV-related head and neck cancer, using it, for example, as a strategy to deescalate patients. That was something we saw this past ASCO from the Dana-Farber group, and also using it to early detect recurrence and potentially intervene earlier for patients with minimal residual disease positivity. So, that remains evolving and as many folks are, I think, already using it in the clinic. But ctDNA also has a lot of potential for HPV-negative head and neck cancer. This is actually a bit more challenging to develop because you don't have that HPV DNA that you can track predictably because the tumor is an HPV- negative disease are much more heterogeneous, but there are a number of data that are coming out both for personalized assays such as Signatera or some of the other assays that require tumor. Unlike colon cancer, which you referenced, where most patients get surgery upfront, in head and neck cancer, many of the patients receive non-surgical pre-chemoradiation. So sometimes the amount of tumor available to generate a personalized assay is more limited and can be one of the challenges that we see in head neck cancer. But certainly that also seems to be emerging. And there's also further assays that are being developed for HPV-negative head neck cancers, such as methylomic signatures and others that may be tissue informed or tissue agnostic. And these are also emerging, particularly in the post-treatment surveillance setting as strong predictors of recurrent disease. So while we're certainly behind some of these other more common tumor types, colon cancer, lung cancer, we're right there with them and more and more trials are going report out, including a number of trials in our upcoming [University of Chicago] Head and Neck Cancer Symposium where I'll be presenting some data and others in the field will be presenting some data looking at ctDNA both for HPV-positive and for HPV- negative to try to improve outcomes for these patients. Dr. Monty Pal: That's so interesting. I've got to tell you that in kidney cancer, what I deal with day to day is a very low shedding disease, right? So techniques as opposed to ctDNA looking for tumor-informed information, that might be less preferred to something like methylomics where you might not necessarily be so contingent on what's happening in the primary tumor. I'm really interested in you mentioning that. Just a point of clarification, this is something I'm trying to wrap my head around. You'd mentioned circulating tumor HPV DNA, right? I assume this is markedly different from just looking for HPV titers in the patient, right? So is this actually incorporated elements of HPV within, you know, essentially host genome, if you will? Dr. Ari Rosenberg: Yeah, correct. This is circulating tumor HPV DNA. And we think of it biologically as a plasma-based tumor DNA biomarker that's specific for HPV-related head and neck cancers. Dr. Monty Pal: Got it, got it. It makes me wonder whether or not this might be applicable to diseases like cervical cancer and so forth where there's also extensively, you know, biology driven by HPV. Is that fair? Dr. Ari Rosenberg: Yes, definitely. And in the head and neck cancer field, much of this ctDNA actually was derived from a different viral mediated head neck cancer, is less common in the U.S., but nasopharyngeal cancer, which is oftentimes associated with EBV. That has been a biomarker for quite some time in nasopharyngeal cancer. Of course, in places where EBV-associated nasopharyngeal cancer, is endemic, such as East Asia, this has been around for quite some time, but we've been using that in the U.S., and there's been trials that have used EBV DNA plasma to predict recurrence and stratify for adjuvant treatment, for example. And so now with HPV, it's much more applicable to our US population because the vast majority of our head and neck cancer patients that we see in the US that are viral mediated in the US tend to be HPV-related. So having assays that we can use to improve outcomes for that biological subset remains of particular interest for us. Dr. Monty Pal: Yeah, that's fascinating. By the way, for the fellows listening, there's tons of boards pearls here that Dr. Rosenberg shared, EBV-associated cancers, the role of HPV and treatment association. So if you're recertifying anytime soon, I definitely think there's notes to take from this conversation indeed. I wanted to shift gears a little bit. And obviously, you're a prolific researcher. I don't think anyone goes through their fellowship in medical oncology without recounting these experiences of our head and neck patients really suffering from treatment-related toxicities. It's a real challenge. And I'm just wondering, I know a big body of work that you're focused on is really using multimodality treatment paradigms to perhaps reduce the cumulative treatment burden of patients with head and neck cancers. Can you talk about that a little bit? Dr. Ari Rosenberg: Yeah, definitely. Thanks for the question. And before I start going into some of the strategies, I'll just say that head and neck cancer, this is particularly for the fellows that are listening as well, just in reference to your prior comment, that this is really a multidisciplinary disease. At our center, all head and neck cancer patients are seen upfront at that first visit by all three specialties, med onc, rad onc, and surgery, because the choice and sequencing of modalities to optimize not only survival, but also functional quality of life outcome is so critical. And I think that's probably the biggest takeaway for anyone who treats a lot of head and neck cancer or will be treating a lot of head and neck cancer in the clinic. But in terms of more specific attempts at trying to optimize some of those parameters that you described, we really think about these separately in terms of HPV-positive and HPV-negative head and neck cancer. For HPV-positive head and neck cancer, the cure rates are quite high with chemo radiation, although not for everyone. There's still about 15, 10 to 15 % of folks that will develop a recurrence. But for the vast majority of patients, standard chemoradiation is quite a cure to therapy, but the toxicity associated with that can be quite substantial. And so there's been a number of attempts to try to deescalate treatment. It turns out that deescalating everyone with locoregionally advanced HPV-positive head and neck cancer is not a good strategy because it's not able to select out the patients that really do need full dose treatment. And we have seen some negative trials that show inferior outcomes when everyone is deescalated. But what does remain promising is again, trying to select out who the best candidates are for deescalated treatment. The folks at MSK have hypoxia imaging that they're using in trials that looks quite promising to select for the more favorable deescalatable biology. At our center, we've been interested in using induction chemotherapy to stratify response and select patients for deescalated treatment with excellent survival outcomes and reduce toxicity with deescalated treatment. And more recently, ctDNA that us and other groups, such as the Dana-Farber group, is using. And that also looks quite promising. Again, how do you select the patient who will do well with less radiation versus the ones that really need the full doses and volumes of radiation? And then for HPV-negative head and neck cancer, this is a much trickier disease because already the survival outcomes are not like we want it to be. Trying to figure out how to improve survival outcomes remains an important thing. Using immunotherapy seems to be one of the key cornerstones to that. But these are patients that also suffer from a lot of toxicity related to their treatment. We completed a trial not too long ago that we published this past year where we, in HPV-negative head and neck cancer patients, de-intensified the radiation for responders to neoadjuvant chemoimmunotherapy. And those patients did similar, if not even a little bit better, than the non-responders who got full dose treatment. So something that does warrant further investigation as well. How do we not only improve survival for those patients, but also reduce some of the long-term toxicities? Dr. Monty Pal: This is brilliant. I'm taking so many notes as you were mentioning these items. There are so many areas where I think the research crosses over. I already mentioned, know, ctDNA, for instance, and metabolomics and the places where that might apply to kidney cancer. The hypoxia imaging really caught my ear too. Obviously, kidney cancer is disease highly predicated on hypoxia. So thank you for all of this. We've got about a minute or so. So, I'm going to ask you for a really tall task here. Can you tell us what you foresee being some of the biggest challenges that sort of lie ahead and head and neck cancer. You've already kind of alluded to it with ongoing research, but if you had to pick maybe 2, 3 problems, the very most that we really need to get to and head and neck cancer, what would that be? Dr. Ari Rosenberg: Yeah, that's a great question. Obviously, lots of things to be done, but if I'm going to limit it to just a couple, I would say number one is really trying to improve the survival for HPV negative local regionally advanced head and neck cancer. We talked early on about how we are seeing, you know, of course we see many of these people that were smokers and drinkers, but also seeing these in younger patients, in patients without a history of tobacco use. Some of these are very biologically aggressive and we need better treatments beyond surgery, beyond chemo radiation, beyond immunotherapy to improve outcomes for these patients and cure more of them. So, I would say that's one big area. And the other is, which we didn't speak about so much in this talk, but remains one of the biggest challenges that we see in the clinic is the recurrent metastatic head and neck cancer patients. This is an incredibly challenging disease to treat, not only with poor survival, but also with substantial impacts on quality of life and function. mean, these are bad recurrences that cause a lot of pain, functional deficits, really impacts quality of life as well. So developing novel therapies, many of which are currently in clinical trials and many of which are currently continuing to be developed, remains so critical. How do we develop better systemic therapies, better targeted therapies, better biomarkers for recurrent metastatic head neck cancer to improve their survival and quality of life and functional outcomes. Those are the two big areas that require the most work at this time within the head and neck cancer field. Dr. Monty Pal: That's brilliant. I mean, I have to tell you I could probably talk to you all day about this, such a fascinating topic. It's a very exciting time in the field. Thank you, Dr. Rosenberg, for all your incredible contributions and thanks for sharing with us your insights on the ASCO Daily News Podcast. Dr. Ari Rosenberg: Yeah, and thanks for the introduction. Hope to do it again soon. Dr. Monty Pal: And many thanks to our listeners for your time today. If you value the insights that you hear from the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. More on today's speakers:      Dr. Monty Pal   @montypal  Dr. Ari Rosenberg @AriRosenbergMD Follow ASCO on social media:           ASCO on X     ASCO on Bluesky          ASCO on Facebook           ASCO on LinkedIn           Disclosures:        Dr. Monty Pal:       Speakers' Bureau: MJH Life Sciences, IntrisiQ, Peerview      Research Funding (Inst.): Exelixis, Merck, Osel, Genentech, Crispr Therapeutics, Adicet Bio, ArsenalBio, Xencor, Miyarsian Pharmaceutical      Travel, Accommodations, Expenses: Crispr Therapeutics, Ipsen, Exelixis  Dr. Ari Rosenberg:     Stock and Other Ownership Interests: Privo Technologies Consulting or Advisory Role: Nanobiotix, EMD Serono, Vaccitech, Novartis, Eisai, Astellas Pharma, Regeneron, RAPT Therapeutics, Geovax Labs, Janssen, Summit Therapeutics Speakers' Bureau: Coherus Biosciences Research Funding (Inst.): Hookipa Biotech, EMD Serono, Purple Biotech, Bristol-Myers Squibb/Celgene, BeiGene, Abbvie, Astellas Pharma, Pfizer, Janux Therapeutics

This episode covers: Cardiology This Week: A concise summary of recent studies Atrial septal defects in adults Conservative and invasive management of chronic coronary syndromes Milestones: 4S trial   Host: Rick Grobbee Guests: JP Carpenter, Annemien van den Bosch, Rasha Al-Lamee, Roxana Mehran Want to watch the episode? Go to: https://esc365.escardio.org/event/2552 Want to watch the extended interview on Atrial septal defects in adults, go to: https://esc365.escardio.org/event/2552?resource=interview Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Rick Grobbee, Nicolle Kraenkel and Annemien van den Bosch have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. Rasha Al-Lamee has declared to have potential conflicts of interest to report:speaker's fees for Menarini pharmaceuticals, Abbott, Philips, Medtronic, Servier, Shockwave, Elixir. Advisory board: Janssen Pharmaceuticals, Abbott, Philips, Shockwave, CathWorks, Elixir, Astrazeneca. Consulting Fees: Menarini pharmaceuticals, Abbott, Philips, Shockwave, Elixir, IsomAB, VahatiCor, SpectraWave, AstraZeneca, Cathworks, Janssen Pharmaceuticals. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Roxana Mehran has declared to have potential conflicts of interest to report: institutional research payments from Abbott, Alleviant Medical, Chiesi, Concept Medical, Cordis, CPC Clinical Research, Daiichi Sankyo, Duke, Faraday Pharmaceuticals, Idorsia Pharmaceuticals, Janssen, MedAlliance, Medtronic, NewAmsterdam Pharma, Novartis, Novo Nordisk Inc., Population Health Research Institute (PHRI), Protembis GmbH, Radcliffe, RM Global Bioaccess Fund Management, Sanofi US Services, Inc. ; personal fees from: None ; Equity

Host: Rick Grobbee Guest: Annemien van den Bosch Want to watch that extended interview on Atrial septal defects in adults, go to: https://esc365.escardio.org/event/2552?resource=interview Want to watch the full episode? Go to: https://esc365.escardio.org/event/2552 Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Rick Grobbee, Nicolle Kraenkel and Annemien van den Bosch have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson

Adjuvant Therapy for Renal Cell Carcinoma Host: Mark L. Gonzalgo, MD, PhD, MBA Guest: Daniel Shapiro, MD, FACS CME Available: https://cme.auanet.org/Users/LearningActivity/LearningActivityDetail.aspx?LearningActivityID=4whvDiMGwrduRsuIIjUIxg%3d%3d ACKNOWLEDGEMENTS: Support provided by an independent educational grant from: Merck & Co., Inc. LEARNING OBJECTIVES: At the conclusion of this activity, participants will be able to: 1. Define adjuvant therapy, review current clinical guidelines, and recognize the current landscape of treatment options for patients with RCC. 2. Compare and contrast different adjuvant therapies available for RCC, including targeted therapies and immunotherapies. 3. Identify common side effects associated with adjuvant therapies for RCC and provide strategies for managing and mitigating these adverse events in clinical practice. 4. Discuss ongoing clinical trials and new therapeutic targets under investigation for adjuvant treatment of RCC.

Medical training is still stuck in the arcade era: expensive, basement-bound simulators and outdated software that rarely capture the real stakes of clinical decision-making. In this episode, host Alexandra Takei, Studio Director at Ruckus Games, sits down with Sam Glassenberg, founder of Level Ex (now part of Relevate Health), to unpack how game developers can modernize healthcare learning by truly embracing the craft of video game design, not “gamification” lipstick. The opportunity and the market here are much bigger than you might assume. Healthcare is a trillion-dollar industry in the US alone, and if you can create products that save the medical system money while also growing the $200B video game industry, that's a win-win. The conversation explores why even mediocre games outperform traditional training (the bar is shockingly low), and how live-ops principles let teams update clinical guidance fast. The pair also discusses who plays these games, and it turns out that it's not only doctors but “normal people” who have found these games on the app store. They go deep on design: mapping real clinical challenges to proven genres (diagnosis as reductive-reasoning puzzles, ventilators as rhythm games), and why domain experts often describe what's hard for residents, not what triggers adrenaline for experts, which is the source of “fun” in games. Finally, Sam breaks down the business: sponsored content by clients like Pfizer and Merck, free-to-play for doctors gameplay, and playable ads. We'd also like to thank Overwolf for making this episode possible! Whether you're a gamer, creator, or game studio, Overwolf is the ultimate destination for integrating UGC in games! You can check out all Overwolf has to offer at https://www.overwolf.com/.If you like the episode, please help others find us by leaving a 5-star rating or review! And if you have any comments, requests, or feedback shoot us a note at podcast@naavik.co. Watch the episode: YouTube ChannelFor more episodes and details: Podcast WebsiteFree newsletter: Naavik DigestFollow us: Twitter | LinkedIn | WebsiteSound design by Gavin Mc Cabe.

In this deeply moving episode of the Modern Mystic Soul Podcast, Therese is joined by Ksenia J. Merck, artist, architect, and creative storyteller whose life's work bridges structure, imagination, and spirit.After more than four decades leading large-scale airport design programs, Ksenia now brings her creative vision to emotional and cosmic landscapes through art and storytelling. Her latest project, Ghost Flower, is a genre-blending science-fiction novel written by her late husband, William F. Merck II, which Ksenia lovingly brought to life through illustration, completion, and posthumous publication.Set in the year 2035 during a global pandemic, Ghost Flower follows a team traveling back to 1585 to uncover the healing power of an ancient extraterrestrial flower, exploring themes of time, memory, leadership, love, and humanity's responsibility to future generations.Together, Therese and Ksenia explore:Completing a loved one's creative work as an act of devotion and healingThe transformative landscape of grief and finding purpose after lossArt as a bridge between memory, spirit, and meaningThe spiritual symbolism woven through Ghost Flower and its companion journalResilience, legacy, and love that transcends time and dimensionThis conversation is a gentle yet powerful reflection on how creativity can become a sacred path through sorrow—and how love continues to guide us long after physical presence fades.

"Brand is your story. That's the one thing that is unique about you." -Nick Usborne   Abe Kasbo is the Founder and CEO of Verasoni, a global marketing communications advisory and agency that delivers integrated strategies for Fortune 500, middle-market, and startup clients, and he serves as a trusted advisor to C-suite leaders on branding, communications, and public relations. He is the author of Irresponsibly Digital, a call to action challenging businesses to rethink digital-first strategies with greater purpose, creativity, and measurable impact, and he has been featured in major outlets including The New York Times, Forbes, PBS, and Fox Business. Abe is an award-winning entrepreneur and humanitarian, including the 2025 Small Business Council of America Humanitarian Award, a documentary filmmaker whose PBS-distributed film The Arab Americans explores 150 years of cultural impact, and a founder of multiple philanthropic initiatives. He is a Seton Hall University Entrepreneur Hall of Fame inductee and holds advanced degrees in public administration, political science, and international relations. Website: https://verasoni.com LinkedIn: https://www.linkedin.com/in/abe-kasbo-3828913/  YouTube: https://www.youtube.com/verasoni   Nick Usborne is a veteran copywriter, trainer, and digital marketing pioneer with over 40 years of experience helping brands and writers create clear, human-centered content. He trains digital marketers, copywriters, and content teams to protect authentic brand stories while using AI responsibly to generate content at scale, through his "AI + Emotional Intelligence" approach. Nick has written for global brands including Apple, Reuters, The New York Times, and Citibank, spoken at leading industry conferences, and led in-house trainings for organizations such as Intuit, Merck, and Walt Disney Attractions. He is widely recognized by industry leaders for his clarity of thought and continues to teach writers how to future-proof their work in the age of AI. Website: https://storyaligned.com/  LinkedIn: https://www.linkedin.com/in/nickusborne/    In this episode, we discover expert insights on blending AI, brand storytelling, and authentic marketing.   Apply to join our marketing mastermind group: https://notypicalmoments.typeform.com/to/hWLDNgjz   Follow No Typical Moments at: Website: https://notypicalmoments.com/ LinkedIn: https://www.linkedin.com/company/no-typical-moments-llc/ YouTube: https://www.youtube.com/channel/UC4G7csw9j7zpjdASvpMzqUA Instagram: https://www.instagram.com/notypicalmoments Facebook: https://www.facebook.com/NTMoments

"Brand is your story. That's the one thing that is unique about you." -Nick Usborne   Abe Kasbo is the Founder and CEO of Verasoni, a global marketing communications advisory and agency that delivers integrated strategies for Fortune 500, middle-market, and startup clients, and he serves as a trusted advisor to C-suite leaders on branding, communications, and public relations. He is the author of Irresponsibly Digital, a call to action challenging businesses to rethink digital-first strategies with greater purpose, creativity, and measurable impact, and he has been featured in major outlets including The New York Times, Forbes, PBS, and Fox Business. Abe is an award-winning entrepreneur and humanitarian, including the 2025 Small Business Council of America Humanitarian Award, a documentary filmmaker whose PBS-distributed film The Arab Americans explores 150 years of cultural impact, and a founder of multiple philanthropic initiatives. He is a Seton Hall University Entrepreneur Hall of Fame inductee and holds advanced degrees in public administration, political science, and international relations. Website: https://verasoni.com LinkedIn: https://www.linkedin.com/in/abe-kasbo-3828913/  YouTube: https://www.youtube.com/verasoni   Nick Usborne is a veteran copywriter, trainer, and digital marketing pioneer with over 40 years of experience helping brands and writers create clear, human-centered content. He trains digital marketers, copywriters, and content teams to protect authentic brand stories while using AI responsibly to generate content at scale, through his "AI + Emotional Intelligence" approach. Nick has written for global brands including Apple, Reuters, The New York Times, and Citibank, spoken at leading industry conferences, and led in-house trainings for organizations such as Intuit, Merck, and Walt Disney Attractions. He is widely recognized by industry leaders for his clarity of thought and continues to teach writers how to future-proof their work in the age of AI. Website: https://storyaligned.com/  LinkedIn: https://www.linkedin.com/in/nickusborne/    In this episode, we discover expert insights on blending AI, brand storytelling, and authentic marketing.   Apply to join our marketing mastermind group: https://notypicalmoments.typeform.com/to/hWLDNgjz   Follow No Typical Moments at: Website: https://notypicalmoments.com/ LinkedIn: https://www.linkedin.com/company/no-typical-moments-llc/ YouTube: https://www.youtube.com/channel/UC4G7csw9j7zpjdASvpMzqUA Instagram: https://www.instagram.com/notypicalmoments Facebook: https://www.facebook.com/NTMoments

Disclosures:Dr. Creech has disclosures of grant funding from NIH, CDC, Moderna, Pfizer and has been a consultant for Merck, Sanofi Paseur, TD. Cowen. Guidepoint Global, GSK, Delbiopharm, Dianthus, AstraZenecka and receives royalties from UpToDateWebsites:Philadelphia Children's Hospital Vaccine Education & ResourcesVUMC Children's Immunization GuideAAPRecommended Books:Anxious Generation: How The Great Rewiring of Childhood Is Causing an Epidemic of Mental Illness, Jonathan HaidtRighteous Mind: Why Good People Are Divided by Politics and Religion, Jonathan HaidtKey TakeawaysRSV prevention now includes both maternal vaccination during third trimester and monoclonal antibodies for infants, both showing 60-80% reduction in hospitalizationsHepatitis B vaccine is fundamentally a cancer prevention tool, and the birth dose is recommended at population level to prevent missed cases even when individual risk appears lowCocooning newborns through family immunization for influenza, pertussis, RSV, and measles is critical as community vaccination rates declineEffective vaccine conversations require avoiding shame and blame, expressing intellectual humility, asking "why" to understand concerns, and providing trusted resources rather than just educationThe future of vaccine development includes improved flu vaccines requiring less frequent administration, alternative delivery methods (intranasal, oral, microneedles), and advanced tools to understand rare adverse eventsWhile vaccine-preventable diseases like measles are increasing in pockets of under-vaccinated communities, maintaining high vaccination rates is essential to prevent widespread outbreaks of highly contagious diseasesParents face significant peer pressure around vaccine decisions, and healthcare providers should acknowledge this while modeling respectful dialogue with those who disagreeQuotable Moments"What is hepatitis B vaccine? It's a cancer prevention vaccine period. It prevents liver cancer. Why would I not want a cancer preventing vaccine?""An ounce of prevention is worth a pound of cure rather than knowing how to treat meningitis really effectively. Wouldn't it be great if we could prevent it all together?""I think we need to recognize that we probably want the same thing, except in extraordinarily weird situations. We both want the health of that child.""I recognize that there is still much to learn about these things, but here's where I land.""Vaccines and your baby's health, that's just more complicated than 140 characters.""Measles is the second most contagious virus on the planet behind smallpox, which is eradicated. So it's the first most...

In this podcast episode, Dr. Jonathan H. Westover talks with Alaina Love about her book, PERMISSION TO BE YOU: Discover Your Purpose And Passions To Bring Your Best Self To Everything – And Everyone.Alaina Love is CEO of Purpose Linked Consulting and a sought-after expert who coaches leaders and their teams on defining their purpose and using their passions to build healthy, productive workplaces and flourish in daily life. She is co-author of the bestselling book The Purpose Linked Organization and was formerly a research scientist and the executive director of global human resources at Merck & Co., Inc. Love is a graduate of the University of Michigan's Change Leadership Program, studied medicine at Tufts University School of Medicine, and holds a degree in medical technology from Monmouth University. Certified as a Senior Professional in Human Resources, Love is a member of Marshall Goldsmith 100 Coaches. An avid leadership thinker, she has written for Bloomberg Business Week, The Washington Post, and Harvard Business Review. Love lives in Raleigh, North Carolina. See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

In this podcast episode, Dr. Jonathan H. Westover talks with Alaina Love about her book, PERMISSION TO BE YOU: Discover Your Purpose And Passions To Bring Your Best Self To Everything – And Everyone. Alaina Love is CEO of Purpose Linked Consulting and a sought-after expert who coaches leaders and their teams on defining their purpose and using their passions to build healthy, productive workplaces and flourish in daily life. She is co-author of the bestselling book The Purpose Linked Organization and was formerly a research scientist and the executive director of global human resources at Merck & Co., Inc. Love is a graduate of the University of Michigan's Change Leadership Program, studied medicine at Tufts University School of Medicine, and holds a degree in medical technology from Monmouth University. Certified as a Senior Professional in Human Resources, Love is a member of Marshall Goldsmith 100 Coaches. An avid leadership thinker, she has written for Bloomberg Business Week, The Washington Post, and Harvard Business Review. Love lives in Raleigh, North Carolina.  Check out all of the podcasts in the HCI Podcast Network!

Can you really deliver speed, quality, and cost in construction—without tradeoffs? In this episode of Construction Genius, Eric Anderton sits down with Ryan Teicher, CEO of REDCOM Design & Construction, to unpack how a fully integrated design-build model eliminates silos, accelerates delivery, and aligns teams around client outcomes. Ryan explains how bringing architecture, engineering, estimating, and construction under one roof leads to faster decisions, fewer conflicts, and better cost control. The conversation dives into early design consulting as a risk filter, sales as true client advocacy, maintaining client intent from concept through construction, and why strong leaders must be willing to walk away from the wrong projects. This is a practical, no-BS conversation about design-build done right, along with CEO-level insights on leadership, culture, and scaling a construction company.  

What does it really mean to become unshakable when your career, your family life, and the world around you all feel uncertain at the same time? In this episode of Becoming Unshakable, I sat down with Christine Ann Miller for a conversation that stayed with me long after we stopped recording. From the very first question, Christine grounds resilience in something more profound than grit or endurance. She shares how becoming unshakable is tied to purpose, faith, and the courage to stay anchored to who you are, even when the path forward is unclear. Christine takes us through her journey as a Jamaican American leader, the first in her family born in the United States, and how growing up around healthcare shaped her desire to solve meaningful problems.  From discovering chemical engineering through an encyclopedia to interning at Merck and dedicating more than three decades to developing medicines that save and improve lives, her story is rooted in service, curiosity, and conviction. She reflects on why purpose matters more than titles and why alignment, not momentum, is what sustains a long career.   The heart of this episode centers on a defining crossroads. Christine shares what it was like to leave a senior role with no next job lined up, only to have the world shut down weeks later during the pandemic. We talk openly about fear, faith, rest, and the discipline of self-leadership when everything familiar disappears. She explains how grounding practices like prayer, meditation, journaling, community, and intentional rest helped her stay receptive to what came next, rather than rushing to force an answer. We also explore the role of support systems, from coaches and therapists to family and trusted friends, and why resilience is rarely built alone. Christine offers thoughtful guidance for anyone who feels like they are barely holding it together right now, reminding us that breathing, connection, service, and reflection are not small acts when life feels heavy. As you listen, consider where you might be rushing past the very pause that could help you hear what is next for you. When things feel shaky in your own life or leadership, what enables you to stay grounded long enough to recognize the opportunity that may already be on its way?  

Jane Hyun is the leading authority for leveraging culture and differences to drive innovation. Often called an "interpreter," she has been a trusted coach for over 20 years to thousands of leaders at Fortune 500 companies including PepsiCo, Clorox, Merck, and USGA, as well as schools and nonprofits, guiding their growth by building their cross-cultural capability. She is the pioneering author of Breaking the Bamboo Ceiling: Leadership Toolkit for Asians and the co-author of Flex: The New Playbook for Managing Across Differences. Through her Cultural Fluency in Leadership Project, Jane enjoys helping leaders forge stronger teams by closing the gaps that get in the way of growth and collaboration.She has been featured on CNN, CNBC, and NPR and has written for Harvard Business Review, Forbes, Fast Company, and The Wall Street Journal on the topics of culture, career development, and onboarding. As a sought-after speaker, Jane has keynoted at Microsoft, ESPN, the International Coaches Federation (ICF), and the Conferences for Women. Recently, Jane received the Marshall Goldsmith 50 Leading Global Coaches Award as the #1 Coach for Cultural Fluency and the NAAAP Vision 100 Award.Her life's calling is to help others flourish in their workplaces and in their communities.In today's episode of Smashing the Plateau, you will learn how to build a meaningful, sustainable consulting practice by leveraging cultural fluency and staying true to your values.Jane and I discuss:Jane's career journey from corporate to consulting [03:02]How Jane developed her cultural fluency specialty [05:27]Assessing and improving cultural fluency in leaders [08:32]How Jane's business has evolved over 20 years [12:31]The importance of saying no to the wrong clients [14:45]The role of community and peer support in business growth [17:42]Integrating personal and professional life as an entrepreneur [19:35]The strategic importance of rest and self-care [22:11]Seeing growth as an iterative process [24:00]Learn more about Jane at: https://www.linkedin.com/in/jane-hyun?utm_source=share&utm_campaign=share_via&utm_content=profile&utm_medium=ios_app , https://www.instagram.com/janehyun_author/, and Substack ______________________________________________________________About Smashing the PlateauSmashing the Plateau shares stories and strategies from corporate refugees: mid-career professionals who've left corporate life to build something of their own.Each episode features a candid conversation with someone who has walked this path or supports those who do. Guests offer real strategies to help you build a sustainable, fulfilling business on your terms, with...

Treatment is a significant part of overcoming breast cancer, but what about the mental, physical and emotional challenges this disease presents? Sarah Cipolla and Tawana Davis both relied on their faith to get through breast cancer. Through it all – the ups and downs and good times and setbacks – they had hope for better days and trusted in their faith. Hope and faith are powerful forces during challenging times. Susan G. Komen leads Worship in Pink, a nationwide program that brings breast health education to faith communities. Through this effort, Komen can reach people who don't participate in breast health care and people who rely on their faith to overcome life's challenges. Thanks to Merck and Novartis for supporting the Worship in Pink Program

How do top sales leaders stay on top in 2026? Seasoned National Sales Director Kristy McCracken shares her secrets.About This EpisodeIn this episode of Medical Sales U, I sit down with Kristy McCracken, a veteran leader in medical devices and biologics. From managing multi-million dollar revenues to leading national teams at companies like Essity and Merck, Kristy knows what it takes to win.We dive deep into:The "Always Learning" Mindset: Why high-level executives are returning to the basics to stay competitive.Modern Networking: How to use LinkedIn and AI to find common ground with hiring managers today.Leadership & Coaching: Kristy shares a powerful story of how she coached an underperforming rep back to success.The Future of Med-Tech: Balancing high-tech AI tools with the "human touch" that closes deals.Whether you are trying to break into medical sales or you're a seasoned pro looking to reinvent your role, Kristy's insights on persistence and "sharpening the saw" are essential listening. Key Moments (Timestamps)00:00 – Introduction: The greatest winners never stop learning.02:15 – Kristy's journey: 20 years in Pharma and Medical Devices.04:30 – Why even National Sales Directors need a "Professional Community."07:45 – Breaking in vs. Leveling up: What has changed in 2026?11:10 – Leadership Deep Dive: Coaching a rep through a PIP (Performance Improvement Plan).15:30 – Networking Secrets: How Kristy landed her latest role using Dave's strategies.19:20 – The Human Element: Asking the "follow-up" question.23:10 – Advice for the next generation of medical sales leaders.Resources & LinksConnect with Kristy McCracken: https://www.linkedin.com/in/kristy-mccracken/READY TO BREAK INTO MEDICAL SALES? We help professionals transition into top-tier medical sales roles: medicalsalesu.com/Kristy mentioned that "Persistence is Key." What is the biggest rejection you've faced in your career, and how did you bounce back? Let us know in the comments!If you found value in this talk, please: SUBSCRIBE for more interviews with industry leaders. LIKE this video to help other medical sales professionals find us. HIT THE BELL so you never miss a coaching session.#MedicalSales #Leadership #CareerGrowth #SalesCoaching #MedTech #MedicalSalesU #Networking2026

Audio roundup of selected biopharma industry content from Scrip over the business week ended February 60, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – Merck looks to fill Keytruda's shoes; Novartis aims to push through largest expiry period; Novo warns of steep sales decline; Pfizer bullish on obesity; and Lilly expects orforglipron success. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-JES32O67YRBSLC6UV2JFY5KPBQ/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Bitcoin is crashing, tech and SaaS stocks are under pressure, and social media is full of panic but dividend investors are staying calm.In this episode, Derek and European DGI explain why this sell-off is sector-specific, not a market crash, and how dividend growth portfolios are holding up surprisingly well during volatility.We discuss:• Why Bitcoin's drop doesn't worry dividend investors• Sector rotation vs. real market crashes• What's happening to tech, SaaS, and AI-exposed stocks• Dividend hikes and earnings updates• How to stay rational when markets get noisyCompanies discussed include Microsoft, Shell, Novo Nordisk, Merck, Brookfield Asset Management, Hershey, PepsiCo, and more.We finish with a listener Q&A covering dividend cuts, price anchoring, currency risk, and investing during market drawdowns.

Investors rotated out of technology stocks into shares more broadly linked to improvements in the economy, Merck was the biggest gainer in the Dow up 3.5 percent, More on the next Pints and Portolios this Saturday February 7th from 12 noon to 2pm with EP Wealth Advisors and Partners CFP Travis McEuen and CMT Nathan Rogers as well as Rob Black in Pleasant Hill with exact location given once you register